| Reported | Recall | Class | Product | Firm |
|---|
| 2025-11-26 | Z-0506-2026 | Class II | Brand Name: HeartMate Product Name: HeartMate 3 Controller | Thoratec LLC |
| 2025-11-26 | Z-0507-2026 | Class II | Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit… | Thoratec LLC |
| 2025-11-26 | Z-0508-2026 | Class II | Brand Name: HeartMate Product Name: HeartMate II¿ Controller | Thoratec LLC |
| 2025-11-26 | Z-0509-2026 | Class II | MC3 VitalFlow Console | Medtronic Perfusion Systems |
| 2025-11-26 | Z-0510-2026 | Class II | MEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D | Medline Industries, LP |
| 2025-11-26 | Z-0511-2026 | Class II | MEDLINE convenience kits labeled as LOCAL BASIC | Medline Industries, LP |
| 2025-11-26 | Z-0512-2026 | Class II | MEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK | Medline Industries, LP |
| 2025-11-26 | Z-0513-2026 | Class II | MEDLINE convenience kits labeled as: 1) GENERAL AAA #11-RF | Medline Industries, LP |
| 2025-11-26 | Z-0514-2026 | Class II | MEDLINE convenience kits labeled as: 1) CENTRAL LINE PACK | Medline Industries, LP |
| 2025-11-26 | Z-0515-2026 | Class II | MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF | Medline Industries, LP |
| 2025-11-26 | Z-0516-2026 | Class II | MEDLINE convenience kits labeled as: 1) HEAD AND NECK | Medline Industries, LP |
| 2025-11-26 | Z-0517-2026 | Class II | MEDLINE convenience kits labeled as: 1) MAJOR LAPAROTOMY CDS | Medline Industries, LP |
| 2025-11-26 | Z-0518-2026 | Class II | MEDLINE convenience kits labeled as: PORT INSERTION PACK | Medline Industries, LP |
| 2025-11-26 | Z-0519-2026 | Class II | MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF | Medline Industries, LP |
| 2025-11-26 | Z-0520-2026 | Class II | MEDLINE convenience kits labeled as: 1) MINOR SINGLE BASIN PACK | Medline Industries, LP |
| 2025-11-26 | Z-0521-2026 | Class II | MEDLINE convenience kits labeled as: 1) GENERAL LAPAROSCOPY | Medline Industries, LP |
| 2025-11-26 | Z-0522-2026 | Class II | MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK | Medline Industries, LP |
| 2025-11-26 | Z-0523-2026 | Class II | MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF | Medline Industries, LP |
| 2025-11-26 | Z-0524-2026 | Class II | MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY CDS #34-RF | Medline Industries, LP |
| 2025-11-26 | Z-0525-2026 | Class II | MEDLINE convenience kits labeled as: CIRCUMCISION PACK | Medline Industries, LP |
| 2025-11-26 | Z-0526-2026 | Class II | MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS | Medline Industries, LP |
| 2025-11-26 | Z-0527-2026 | Class II | MEDLINE convenience kits labeled as: 1) GYN LAPAROTOMY HARPER PACK-LF | Medline Industries, LP |
| 2025-11-26 | Z-0528-2026 | Class II | MEDLINE convenience kits labeled as: GP-LEEP PACK-LF | Medline Industries, LP |
| 2025-11-26 | Z-0529-2026 | Class II | MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81 | Medline Industries, LP |
| 2025-11-26 | Z-0530-2026 | Class II | MEDLINE convenience kits labeled as: 1) NEURO CRANIOTOMY CDS #36-RF | Medline Industries, LP |
| 2025-11-26 | Z-0533-2026 | Class II | PhD Hemostasis Valve | Merit Medical Systems, Inc. |
| 2025-11-26 | Z-0534-2026 | Class II | Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme… | Quest International, Inc. |
| 2025-11-26 | Z-0535-2026 | Class II | Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer | Exactech, Inc. |
| 2025-11-26 | Z-0536-2026 | Class II | Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer | Exactech, Inc. |
| 2025-11-26 | Z-0537-2026 | Class II | Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip… | Exactech, Inc. |
| 2025-11-26 | Z-0538-2026 | Class III | OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin… | POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC |
| 2025-11-26 | Z-0539-2026 | Class II | Medtronic HR-ACT | Medtronic Perfusion Systems |
| 2025-11-26 | Z-0540-2026 | Class II | Tribio Implant 7 | Berkeley Advanced Biomaterials, LLC |
| 2025-11-26 | Z-0541-2026 | Class II | DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code:… | Beckman Coulter Inc. |
| 2025-11-26 | Z-0542-2026 | Class II | REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer… | Cellavision AB |
| 2025-11-26 | Z-0543-2026 | Class II | MONARCH Bronchoscope | Auris Health, Inc |
| 2025-11-26 | Z-0544-2026 | Class II | SAFE-T-FILL Micro Capillary Blood Collection | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| 2025-11-26 | Z-0545-2026 | Class II | SAFE-T-FILL Micro Capillary Blood Collection | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| 2025-11-26 | Z-0546-2026 | Class II | SAFE-T-FILL Micro Capillary Blood Collection | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| 2025-11-26 | Z-0547-2026 | Class II | SAFE-T-FILL Micro Capillary Blood Collection | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| 2025-11-26 | Z-0548-2026 | Class II | SAFE-T-FILL Micro Capillary Blood Collection | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| 2025-11-26 | Z-0549-2026 | Class II | AFE-T-FILL Micro Capillary Blood Collection | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| 2025-11-26 | Z-0550-2026 | Class II | SAFE-T-FILL Micro Capillary Blood Collection | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| 2025-11-26 | Z-0551-2026 | Class II | SAFE-T-FILL Micro Capillary Blood Collection | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| 2025-11-26 | Z-0552-2026 | Class II | SAFE-T-FILL Micro Capillary Blood Collection | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| 2025-11-26 | Z-0553-2026 | Class II | SAFE-T-FILL Micro Capillary Blood Collection | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| 2025-11-26 | Z-0554-2026 | Class II | SAFE-T-FILL Micro Capillary Blood Collection | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| 2025-11-26 | Z-0555-2026 | Class II | SAFE-T-FILL MicroHematocrit Capillary Tubes | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| 2025-11-26 | Z-0556-2026 | Class II | SAFE-T-FILL MicroHematocrit Capillary Tubes | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| 2025-11-26 | Z-0557-2026 | Class II | SAFE-T-FILL Plastic Blood Gas Capillary Tubes | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| 2025-11-26 | Z-0558-2026 | Class II | SAFE-T-FILL Plastic Blood Gas Capillary Tubes | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| 2025-11-26 | Z-0559-2026 | Class II | SAFE-T-FILL Plastic Blood Gas Capillary Tubes | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| 2025-11-26 | Z-0560-2026 | Class II | SAFE-T-FILL Plastic Blood Gas Capillary Tubes | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| 2025-11-26 | Z-0561-2026 | Class II | SAFE-T-FILL Plastic Blood Gas Capillary Tubes | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| 2025-11-26 | Z-0562-2026 | Class II | SAFE-T-FILL Plastic Blood Gas Capillary Tubes | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| 2025-11-26 | Z-0563-2026 | Class II | SAFE-T-FILL Plastic Blood Gas Capillary Tubes | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| 2025-11-26 | Z-0564-2026 | Class II | SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| 2025-11-26 | Z-0565-2026 | Class II | SAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| 2025-11-26 | Z-0566-2026 | Class II | Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| 2025-11-26 | Z-0567-2026 | Class II | SAFE-T-FILL Micro Collection Tube Extender | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| 2025-11-26 | Z-0568-2026 | Class II | Meridian Bioscience | Meridian Bioscience Inc |
| 2025-11-26 | Z-0569-2026 | Class II | Meridian Bioscience | Meridian Bioscience Inc |
| 2025-11-26 | Z-0571-2026 | Class II | Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot… | Greiner Bio-One North America, Inc. |
| 2025-11-26 | Z-0572-2026 | Class II | Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation… | Olympus Corporation of the Americas |
| 2025-11-26 | Z-0573-2026 | Class II | Brand Name: ACUSON | Sterilmed, Inc. |
| 2025-11-26 | Z-0574-2026 | Class II | Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name:… | Sterilmed, Inc. |
| 2025-11-19 | Z-0431-2026 | Class I | MAGNETOM Cima | Siemens Medical Solutions USA, Inc |
| 2025-11-19 | Z-0434-2026 | Class I | CEREPAK Detachable Coil System | Cerenovus Inc |
| 2025-11-19 | Z-0442-2026 | Class I | Anesthesia Circuit Kits and other various kits that contain… | Medline Industries, LP |
| 2025-11-19 | Z-0443-2026 | Class I | Anesthesia Circuit Kits and other various kits that contain… | Medline Industries, LP |
| 2025-11-19 | Z-0444-2026 | Class I | Anesthesia Circuit Kits and other various kits that contain… | Medline Industries, LP |
| 2025-11-19 | Z-0445-2026 | Class I | Anesthesia Circuit Kits and other various kits that contain… | Medline Industries, LP |
| 2025-11-19 | Z-0446-2026 | Class I | DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO… | Medline Industries, LP |
| 2025-11-19 | Z-0447-2026 | Class I | Convenience Kit | Medline Industries, LP |
| 2025-11-19 | Z-0448-2026 | Class I | Convenience Kits: DYNJ901048N ORTHO SPINE ST CLAIR DYNJ909123F… | Medline Industries, LP |
| 2025-11-19 | Z-0449-2026 | Class I | Anesthesia circuit kit | Medline Industries, LP |
| 2025-11-19 | Z-0450-2026 | Class I | Convenience kits | Medline Industries, LP |
| 2025-11-19 | Z-0451-2026 | Class I | Convenience kits | Medline Industries, LP |
| 2025-11-19 | Z-0452-2026 | Class II | Brand Name: Lithotriptor | Olympus Corporation of the Americas |
| 2025-11-19 | Z-0453-2026 | Class II | Carescape B450 | GE Healthcare Finland Oy |
| 2025-11-19 | Z-0454-2026 | Class II | CARESCAPE ONE | GE Healthcare Finland Oy |
| 2025-11-19 | Z-0455-2026 | Class II | B105P | GE Healthcare Finland Oy |
| 2025-11-19 | Z-0456-2026 | Class II | Portrait VSM Model nos | GE Healthcare Finland Oy |
| 2025-11-19 | Z-0457-2026 | Class II | BATTERY FLEX-3S2P 10 | GE Healthcare Finland Oy |
| 2025-11-19 | Z-0458-2026 | Class II | Eterna SCS IPG | Abbott Medical |
| 2025-11-19 | Z-0459-2026 | Class II | Liberta RC DBS IPG | Abbott Medical |
| 2025-11-19 | Z-0460-2026 | Class II | Brand Name: Sonesta Product Name: 6210 Model/Catalog Number:… | Sonesta Medical AB |
| 2025-11-19 | Z-0461-2026 | Class II | ProxiDiagnost N90 | Philips Medical Systems DMC GmbH |
| 2025-11-19 | Z-0462-2026 | Class II | CombiDiagnost R90 | Philips Medical Systems DMC GmbH |
| 2025-11-19 | Z-0463-2026 | Class II | Precision CRF | Philips Medical Systems DMC GmbH |
| 2025-11-19 | Z-0464-2026 | Class II | DigitalDiagnost 4 | Philips Medical Systems DMC GmbH |
| 2025-11-19 | Z-0465-2026 | Class II | DigitalDiagnost C90 | Philips Medical Systems DMC GmbH |
| 2025-11-19 | Z-0466-2026 | Class II | Radiography 7300 C | Philips Medical Systems DMC GmbH |
| 2025-11-19 | Z-0467-2026 | Class II | Medline Renewal LigaSure Exact | Medline Industries, LP |
| 2025-11-19 | Z-0468-2026 | Class II | Medline Renewal LigaSure Impact Curved Large Jaw Sealer/Divider | Medline Industries, LP |
| 2025-11-19 | Z-0469-2026 | Class II | Medline Renewal Ligasure Impact Sealer/Divider NanoCoated | Medline Industries, LP |
| 2025-11-19 | Z-0470-2026 | Class II | Medline Renewal LigaSure Small Jaw Instrument | Medline Industries, LP |
| 2025-11-19 | Z-0471-2026 | Class II | Medline Renewal LigaSure Blunt Tip Sealer/Divider | Medline Industries, LP |
| 2025-11-19 | Z-0472-2026 | Class II | Medline RenewalLigasure Blunt Tip Sealer/Divider | Medline Industries, LP |
| 2025-11-19 | Z-0473-2026 | Class II | Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated | Medline Industries, LP |
| 2025-11-19 | Z-0474-2026 | Class II | Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated | Medline Industries, LP |
| 2025-11-19 | Z-0475-2026 | Class II | Medline Renewal LigaSure Maryland Jaw Sealer/Divider Nano Coated | Medline Industries, LP |
| 2025-11-19 | Z-0476-2026 | Class II | Medline Renewal LigaSure Maryland Jaw Sealer/Divider NanoCoated | Medline Industries, LP |
| 2025-11-19 | Z-0477-2026 | Class II | Medline Renewal Ligasure Maryland Jaw Sealer/Divider NanoCoated | Medline Industries, LP |
| 2025-11-19 | Z-0478-2026 | Class II | Virata Preassembled Polyaxial Screw | Orthofix U.S. LLC |
| 2025-11-19 | Z-0479-2026 | Class II | BEAR Implant | Miach Orthopaedics |
| 2025-11-19 | Z-0480-2026 | Class II | GM85 Digital Mobile X-ray imaging System | NeuroLogica Corporation |
| 2025-11-19 | Z-0481-2026 | Class II | SimplyGo Mini | Philips Respironics, Inc. |
| 2025-11-19 | Z-0482-2026 | Class II | Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product… | Olympus Corporation of the Americas |
| 2025-11-19 | Z-0483-2026 | Class II | Brand Name: Olympus Single Use Single Use Electrosurgical Snare… | Olympus Corporation of the Americas |
| 2025-11-19 | Z-0484-2026 | Class II | BD Kiestra" Isolate Suspension Cuvette Array | Becton Dickinson & Co. |
| 2025-11-19 | Z-0485-2026 | Class II | Covidien Signia" Small Diameter Curved Tip Intelligent Reload | Covidien, LP |
| 2025-11-19 | Z-0486-2026 | Class II | Covidien Signia" Small Diameter Curved Tip Intelligent Reload | Covidien, LP |
| 2025-11-19 | Z-0487-2026 | Class II | Affinity NT Oxygenator | Medtronic Perfusion Systems |
| 2025-11-19 | Z-0489-2026 | Class II | Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer… | Abbott Laboratories |
| 2025-11-19 | Z-0490-2026 | Class II | HARMONIC FOCUS Shears + Adaptive Tissue Technology | Stryker Sustainability Solutions |
| 2025-11-19 | Z-0491-2026 | Class II | IMMULITE 2000 Oak Mix Specific Allergen | Siemens Healthcare Diagnostics, Inc. |
| 2025-11-19 | Z-0492-2026 | Class II | 3gAllergy Specific IgE Universal Kit | Siemens Healthcare Diagnostics, Inc. |
| 2025-11-19 | Z-0493-2026 | Class II | Food Panel 3 Specific Allergen | Siemens Healthcare Diagnostics, Inc. |
| 2025-11-19 | Z-0494-2026 | Class II | Applied Medical Technology | Applied Medical Technology Inc |
| 2025-11-19 | Z-0495-2026 | Class II | Applied Medical Technology | Applied Medical Technology Inc |
| 2025-11-19 | Z-0496-2026 | Class II | Applied Medical Technology | Applied Medical Technology Inc |
| 2025-11-19 | Z-0497-2026 | Class II | Applied Medical Technology | Applied Medical Technology Inc |
| 2025-11-19 | Z-0498-2026 | Class II | Applied Medical Technology | Applied Medical Technology Inc |
| 2025-11-19 | Z-0499-2026 | Class II | Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with… | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION |
| 2025-11-19 | Z-0500-2026 | Class III | VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code:… | Accriva Diagnostics, Inc. |
| 2025-11-19 | Z-0501-2026 | Class II | Multichem ID-B | TECHNO-PATH MANUFACTURING LTD. |
| 2025-11-19 | Z-0502-2026 | Class II | Multichem ID-B | TECHNO-PATH MANUFACTURING LTD. |
| 2025-11-12 | Z-0313-2026 | Class II | Osstem Dental X-Ray System T1 | OSSTEM Implant Co., Ltd. |
| 2025-11-12 | Z-0314-2026 | Class II | Osstem Dental X-Ray System T2 | OSSTEM Implant Co., Ltd. |
| 2025-11-12 | Z-0315-2026 | Class II | Osstem Dental X-Ray System T2Plus | OSSTEM Implant Co., Ltd. |
| 2025-11-12 | Z-0373-2026 | Class I | CODMAN Disposable Perforator 11mm | Integra LifeSciences Corp. (NeuroSciences) |
| 2025-11-12 | Z-0374-2026 | Class I | CODMAN Disposable Perforator 9mm | Integra LifeSciences Corp. (NeuroSciences) |
| 2025-11-12 | Z-0416-2026 | Class II | Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog… | Spacelabs Healthcare, Ltd. |
| 2025-11-12 | Z-0417-2026 | Class II | Brand Name: Inclusive Product Name: Inclusive Titanium Screw… | Prismatik Dentalcraft, Inc. |
| 2025-11-12 | Z-0418-2026 | Class II | Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene | Zimmer, Inc. |
| 2025-11-12 | Z-0419-2026 | Class II | Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene | Zimmer, Inc. |
| 2025-11-12 | Z-0420-2026 | Class II | TruDi¿ Navigation System | Integra LifeSciences Corp. (NeuroSciences) |
| 2025-11-12 | Z-0421-2026 | Class II | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved… | Mozarc Medical US LLC |
| 2025-11-12 | Z-0422-2026 | Class II | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved… | Mozarc Medical US LLC |
| 2025-11-12 | Z-0423-2026 | Class II | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved… | Mozarc Medical US LLC |
| 2025-11-12 | Z-0424-2026 | Class II | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight… | Mozarc Medical US LLC |
| 2025-11-12 | Z-0425-2026 | Class II | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight… | Mozarc Medical US LLC |
| 2025-11-12 | Z-0426-2026 | Class II | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight… | Mozarc Medical US LLC |
| 2025-11-12 | Z-0427-2026 | Class I | Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps… | Tandem Diabetes Care, Inc. |
| 2025-11-12 | Z-0428-2026 | Class II | Beckman Coulter UniCel DxI 600 | Beckman Coulter, Inc. |
| 2025-11-12 | Z-0429-2026 | Class II | Beckman Coulter UniCel DxI 800 | Beckman Coulter, Inc. |
| 2025-11-12 | Z-0432-2026 | Class II | Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205 | Total Joint Orthopedics, Inc. |
| 2025-11-12 | Z-0433-2026 | Class II | Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage… | Elekta, Inc. |
| 2025-11-12 | Z-0435-2026 | Class II | 1202 Flex Focus Ultrasound System | B-K Medical A/S |
| 2025-11-12 | Z-0436-2026 | Class II | Ultrasound System 1300 | B-K Medical A/S |
| 2025-11-12 | Z-0437-2026 | Class II | UUltrasound System 2300 | B-K Medical A/S |
| 2025-11-12 | Z-0438-2026 | Class II | bk3000 Ultrasound System w/battery | B-K Medical A/S |
| 2025-11-12 | Z-0439-2026 | Class II | bk3500 Ultrasound System w/battery | B-K Medical A/S |
| 2025-11-12 | Z-0440-2026 | Class II | bk5000 Ultrasound System w/battery | B-K Medical A/S |
| 2025-11-12 | Z-0441-2026 | Class II | SYNCHRON Systems Direct LDL Cholesterol | Beckman Coulter Inc. |
| 2025-11-05 | Z-0161-2026 | Class I | IMRIS Operating Suite | IMPRIS Imaging Inc |
| 2025-11-05 | Z-0162-2026 | Class I | IMRIS Operating Suite | IMPRIS Imaging Inc |
| 2025-11-05 | Z-0163-2026 | Class I | IMRIS Operating Suite | IMPRIS Imaging Inc |
| 2025-11-05 | Z-0164-2026 | Class I | IMRIS Operating Suite | IMPRIS Imaging Inc |
| 2025-11-05 | Z-0188-2026 | Class I | Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega… | BALT USA, LLC |
| 2025-11-05 | Z-0304-2026 | Class II | Brand Name: Alcon Laboratories | Alcon Research LLC |
| 2025-11-05 | Z-0305-2026 | Class II | Brand Name: Alcon Laboratories | Alcon Research LLC |
| 2025-11-05 | Z-0306-2026 | Class II | Brand Name: Alcon Laboratories | Alcon Research LLC |
| 2025-11-05 | Z-0307-2026 | Class II | Brand Name: Alcon Laboratories | Alcon Research LLC |
| 2025-11-05 | Z-0308-2026 | Class II | Brand Name: Alcon Laboratories | Alcon Research LLC |
| 2025-11-05 | Z-0309-2026 | Class II | Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W | Aesculap Inc |
| 2025-11-05 | Z-0310-2026 | Class II | Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS… | Aesculap Inc |
| 2025-11-05 | Z-0311-2026 | Class II | Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS… | Aesculap Inc |
| 2025-11-05 | Z-0312-2026 | Class II | Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM… | Aesculap Inc |
| 2025-11-05 | Z-0316-2026 | Class II | Magseed Pro 7 cm soft tissue marker | ENDOMAGNETICS LTD |
| 2025-11-05 | Z-0317-2026 | Class II | Magseed Pro 12 cm soft tissue marker | ENDOMAGNETICS LTD |
| 2025-11-05 | Z-0318-2026 | Class I | Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product… | Dexcom, Inc. |
| 2025-11-05 | Z-0319-2026 | Class II | SuRgical Planner | Surgical Theater Inc |
| 2025-11-05 | Z-0320-2026 | Class II | Surgical Navigation Advanced Platform | Surgical Theater Inc |
| 2025-11-05 | Z-0321-2026 | Class II | Surgical Navigation Advanced Platform Patient Engagement | Surgical Theater Inc |
| 2025-11-05 | Z-0322-2026 | Class II | SyncAR Surgical Navigation Advanced Platform Patient Engagement | Surgical Theater Inc |
| 2025-11-05 | Z-0323-2026 | Class II | Endo Surgical Navigation Advanced Platform Patient Engagement | Surgical Theater Inc |
| 2025-11-05 | Z-0324-2026 | Class II | SpineAR Surgical Navigation Advanced Platform Patient Engagement | Surgical Theater Inc |
| 2025-11-05 | Z-0325-2026 | Class II | Surgical Planner | Surgical Theater Inc |
| 2025-11-05 | Z-0326-2026 | Class II | Alcon PRECISION1 One-Day Contact Lenses | Alcon Research LLC |
| 2025-11-05 | Z-0327-2026 | Class II | VANTAGE GALAN 3T | Canon Medical System, USA, INC. |
| 2025-11-05 | Z-0328-2026 | Class II | ChemoLock Bag Spike | ICU Medical, Inc. |
| 2025-11-05 | Z-0329-2026 | Class II | ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10 | ICU Medical, Inc. |
| 2025-11-05 | Z-0330-2026 | Class II | ICU Medical ChemoLock" Port | ICU Medical, Inc. |
| 2025-11-05 | Z-0331-2026 | Class II | ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150 | ICU Medical, Inc. |
| 2025-11-05 | Z-0332-2026 | Class II | ICU Medical 30" | ICU Medical, Inc. |
| 2025-11-05 | Z-0333-2026 | Class II | ICU Medical 30" | ICU Medical, Inc. |
| 2025-11-05 | Z-0334-2026 | Class II | ICU Medical Oncology Kit w/31" | ICU Medical, Inc. |
| 2025-11-05 | Z-0335-2026 | Class II | ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940 | ICU Medical, Inc. |
| 2025-11-05 | Z-0336-2026 | Class II | ICU Medical Oncology Kit w/ChemoLock | ICU Medical, Inc. |
| 2025-11-05 | Z-0337-2026 | Class II | ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port | ICU Medical, Inc. |
| 2025-11-05 | Z-0338-2026 | Class II | ICU Medical 45" | ICU Medical, Inc. |
| 2025-11-05 | Z-0339-2026 | Class II | ICU Medical 60" | ICU Medical, Inc. |
| 2025-11-05 | Z-0340-2026 | Class II | ICU Medical 73" | ICU Medical, Inc. |
| 2025-11-05 | Z-0341-2026 | Class II | ICU Medical ChemoLock Bag Spike REF: CL-10 | ICU Medical, Inc. |
| 2025-11-05 | Z-0342-2026 | Class II | ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33 | ICU Medical, Inc. |
| 2025-11-05 | Z-0343-2026 | Class II | ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70 | ICU Medical, Inc. |
| 2025-11-05 | Z-0344-2026 | Class II | ICU Medical ChemoLock Vented Vial Spike | ICU Medical, Inc. |
| 2025-11-05 | Z-0345-2026 | Class II | ICU Medical ChemoLock Vented Vial Spike | ICU Medical, Inc. |