| Reported | Recall | Class | Product | Firm |
|---|
| 2018-12-26 | Z-0497-2019 | Class I | Puritan Bennett 980 | COVIDIEN LLC |
| 2018-12-26 | Z-0609-2019 | Class II | Carousel MAS1025-01 | Mazor Robotics Ltd |
| 2018-12-26 | Z-0610-2019 | Class II | Staclot¿ LA | Diagnostica Stago, Inc. |
| 2018-12-26 | Z-0611-2019 | Class II | Staclot LA 20 | Diagnostica Stago, Inc. |
| 2018-12-26 | Z-0613-2019 | Class II | AIA-360 Analyzer is capable of performing two methods of immunoassay:… | Tosoh Bioscience Inc |
| 2018-12-26 | Z-0614-2019 | Class II | Xper Flex Cardio Physiomonitoring System | Philips Electronics North America Corporation |
| 2018-12-26 | Z-0615-2019 | Class II | Abbott i-STAT CG8+ Cartridges intended for use in the in vitro… | Abbott Point Of Care Inc. |
| 2018-12-26 | Z-0616-2019 | Class II | Dimension Vista 500 | Siemens Healthcare Diagnostics, Inc. |
| 2018-12-26 | Z-0617-2019 | Class II | Dimension Vista 1500 | Siemens Healthcare Diagnostics, Inc. |
| 2018-12-26 | Z-0618-2019 | Class II | VITEK 2 Antimicrobial Susceptibility Testing | bioMerieux, Inc. |
| 2018-12-26 | Z-0619-2019 | Class II | SAPPHIRE Epidural Set Yellow-Striped Microbore | ICU Medical Inc |
| 2018-12-26 | Z-0620-2019 | Class II | ultra2 Genesys Variants Analyzer | Clark Laboratories, Inc. (dba,Trinity Biotech USA) |
| 2018-12-26 | Z-0621-2019 | Class II | Genesys Analytical Column | Clark Laboratories, Inc. (dba,Trinity Biotech USA) |
| 2018-12-26 | Z-0622-2019 | Class II | Genesys 1 Reagent | Clark Laboratories, Inc. (dba,Trinity Biotech USA) |
| 2018-12-26 | Z-0623-2019 | Class II | Genesys 2 Reagent | Clark Laboratories, Inc. (dba,Trinity Biotech USA) |
| 2018-12-26 | Z-0624-2019 | Class II | Genesys Diluent Reagent | Clark Laboratories, Inc. (dba,Trinity Biotech USA) |
| 2018-12-26 | Z-0625-2019 | Class II | Covidien Emprint Long Percutaneous Antenna with Thermosphere… | Covidien LLC |
| 2018-12-26 | Z-0626-2019 | Class II | Covidien Emprint Short Percutaneous Antenna with Thermosphere… | Covidien LLC |
| 2018-12-26 | Z-0627-2019 | Class II | Covidien Emprint Standard Percutaneous Antenna with Thermosphere… | Covidien LLC |
| 2018-12-26 | Z-0628-2019 | Class II | enVista One Piece Hydrophobic Acrylic Intraocular lens | Bausch & Lomb Surgical, Inc. |
| 2018-12-26 | Z-0629-2019 | Class II | Jarvik 2000 Ventricular Assist System external components: JHI-212 Y… | Jarvik Heart Inc |
| 2018-12-26 | Z-0630-2019 | Class II | NexGen¿ Complete Knee Solution Femoral Augment Block Distal only | Zimmer Biomet, Inc. |
| 2018-12-26 | Z-0631-2019 | Class II | Protexis Neoprene Surgical Glove | Cardinal Health 200, LLC |
| 2018-12-26 | Z-0632-2019 | Class II | Protexis Neoprene Surgical Glove | Cardinal Health 200, LLC |
| 2018-12-26 | Z-0633-2019 | Class II | Protexis Neoprene Surgical Glove | Cardinal Health 200, LLC |
| 2018-12-26 | Z-0634-2019 | Class II | Protexis Neoprene Surgical Glove | Cardinal Health 200, LLC |
| 2018-12-26 | Z-0635-2019 | Class II | Protexis Neoprene Surgical Glove | Cardinal Health 200, LLC |
| 2018-12-26 | Z-0636-2019 | Class II | Protexis Neoprene Surgical Glove | Cardinal Health 200, LLC |
| 2018-12-26 | Z-0637-2019 | Class II | Protexis Neoprene Surgical Glove | Cardinal Health 200, LLC |
| 2018-12-26 | Z-0638-2019 | Class II | Protexis Neoprene Surgical Glove | Cardinal Health 200, LLC |
| 2018-12-26 | Z-0639-2019 | Class II | VITEK¿ 2 Systems Software Version 9 | bioMerieux, Inc. |
| 2018-12-26 | Z-0640-2019 | Class II | GloCyte RBC Reagent | Advanced Instruments, LLC |
| 2018-12-26 | Z-0641-2019 | Class II | Centricity Universal Viewer Zero Footprint Client | GE Healthcare, LLC |
| 2018-12-26 | Z-0642-2019 | Class II | Zimmer Compress Devices and Instruments: Item Number/Item Description… | Zimmer Biomet, Inc. |
| 2018-12-26 | Z-0643-2019 | Class II | Theragenics Applicator Needle | Theragenics Corporation |
| 2018-12-26 | Z-0644-2019 | Class II | Avenir¿ Muller Stem Standard | Zimmer GmbH |
| 2018-12-26 | Z-0645-2019 | Class II | IMRIS T2X table | Deerfield Imaging, Inc. |
| 2018-12-26 | Z-0646-2019 | Class II | IMRIS ORT 100 table | Deerfield Imaging, Inc. |
| 2018-12-26 | Z-0647-2019 | Class II | IMRIS ORT 200 | Deerfield Imaging, Inc. |
| 2018-12-26 | Z-0648-2019 | Class II | IMRIS ORT 300 | Deerfield Imaging, Inc. |
| 2018-12-26 | Z-0649-2019 | Class II | FoundationOne CDx Test Results | Foundation Medicine, Inc. |
| 2018-12-26 | Z-0650-2019 | Class II | VITROS 5600 Integrated System | Ortho-Clinical Diagnostics |
| 2018-12-26 | Z-0651-2019 | Class II | VITROS 5 | Ortho-Clinical Diagnostics |
| 2018-12-26 | Z-0652-2019 | Class II | VITROS¿ 3600 Immunodiagnostic System | Ortho-Clinical Diagnostics |
| 2018-12-26 | Z-0653-2019 | Class II | VITROS 4600 Chemistry System | Ortho-Clinical Diagnostics |
| 2018-12-26 | Z-0654-2019 | Class II | Empower FastLoad CT Syringe Pack -sterile disposable syringe kit for… | Bracco Injeneering S.A. |
| 2018-12-26 | Z-0655-2019 | Class III | RT-5100 Refractor | Nidek Inc. |
| 2018-12-26 | Z-0656-2019 | Class II | 8Fr SAFE GRAD CAT W/Valve | COVIDIEN LLC |
| 2018-12-26 | Z-0657-2019 | Class II | Reliance LITe Nerve Hook Bayoneted | Howmedica Osteonics Corp. |
| 2018-12-26 | Z-0658-2019 | Class II | Optiflux F160NR Capillary High Flux Dialyzer Single Use Only | Fresenius Medical Care Renal Therapies Group, LLC |
| 2018-12-26 | Z-0659-2019 | Class II | Bucky Stand SU-4000 Input 2017 | Konica Minolta Healthcare, Americas, Inc. |
| 2018-12-19 | Z-0562-2019 | Class II | CIVCO Needle Guide Bracket | CIVCO Medical Instruments Co., Inc. |
| 2018-12-19 | Z-0563-2019 | Class II | SonoSite L25 Bracket Kit containing 1 Reusable non-sterile bracket | CIVCO Medical Instruments Co., Inc. |
| 2018-12-19 | Z-0564-2019 | Class II | CIVCO Needle Guide Bracket | CIVCO Medical Instruments Co., Inc. |
| 2018-12-19 | Z-0565-2019 | Class II | CIVCO Biopsy Bracket | CIVCO Medical Instruments Co., Inc. |
| 2018-12-19 | Z-0566-2019 | Class II | SonoSite Needle Guide Bracket | CIVCO Medical Instruments Co., Inc. |
| 2018-12-19 | Z-0567-2019 | Class II | SonoSite FUJIFILM Needle Guide Bracket | CIVCO Medical Instruments Co., Inc. |
| 2018-12-19 | Z-0568-2019 | Class II | CIVCO Needle Guide Starter Kit | CIVCO Medical Instruments Co., Inc. |
| 2018-12-19 | Z-0569-2019 | Class II | CIVCO Needle Guide Starter Kit | CIVCO Medical Instruments Co., Inc. |
| 2018-12-19 | Z-0570-2019 | Class II | CIVCO Needle Guide Starter Kit | CIVCO Medical Instruments Co., Inc. |
| 2018-12-19 | Z-0571-2019 | Class II | CIVCO Needle Guide Starter Kit | CIVCO Medical Instruments Co., Inc. |
| 2018-12-19 | Z-0572-2019 | Class II | CIVCO Needle Guide Starter Kit | CIVCO Medical Instruments Co., Inc. |
| 2018-12-19 | Z-0573-2019 | Class II | CIVCO Needle Guide Starter Kit | CIVCO Medical Instruments Co., Inc. |
| 2018-12-19 | Z-0574-2019 | Class II | CIVCO Needle Guide Bracket | CIVCO Medical Instruments Co., Inc. |
| 2018-12-19 | Z-0575-2019 | Class II | CIVCO Needle Guide Bracket | CIVCO Medical Instruments Co., Inc. |
| 2018-12-19 | Z-0576-2019 | Class II | CIVCO Sales Demo Kit | CIVCO Medical Instruments Co., Inc. |
| 2018-12-19 | Z-0577-2019 | Class II | Laser Fiber Assy-Single Use-LFS-272-RT-0 | Leoni Fiber Optics GmbH |
| 2018-12-19 | Z-0578-2019 | Class II | Laser Fiber Assy-Single Use-LFS-365-RT-0 | Leoni Fiber Optics GmbH |
| 2018-12-19 | Z-0579-2019 | Class II | Laser Fiber Assy-Single Use-LFS-550-RT-0 | Leoni Fiber Optics GmbH |
| 2018-12-19 | Z-0580-2019 | Class II | Laser Fiber Assy-Single Use-LFS-940-RT-0 | Leoni Fiber Optics GmbH |
| 2018-12-19 | Z-0581-2019 | Class II | Laser Fiber Assy-Single Use-LFS-200-0 | Leoni Fiber Optics GmbH |
| 2018-12-19 | Z-0582-2019 | Class II | Medtronic HeartWare Ventricular Assist HVAD System Battery Charger… | Heartware, Inc. |
| 2018-12-19 | Z-0583-2019 | Class II | PROCARE B20 Patient Monitor | GE Healthcare, LLC |
| 2018-12-19 | Z-0584-2019 | Class II | PROCARE B40 Patient Monitor | GE Healthcare, LLC |
| 2018-12-19 | Z-0585-2019 | Class II | B20i Patient Monitor and B20i V2 Patient Monitor | GE Healthcare, LLC |
| 2018-12-19 | Z-0586-2019 | Class II | B40i Patient Monitor and B40i Patient Monitor V3 The device is a… | GE Healthcare, LLC |
| 2018-12-19 | Z-0587-2019 | Class II | B105/125 Patient Monitor | GE Healthcare, LLC |
| 2018-12-19 | Z-0588-2019 | Class II | GE LOGIQ E10 Ultrasound System | GE Healthcare, LLC |
| 2018-12-19 | Z-0589-2019 | Class II | ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling | ARJOHUNTLEIGH POLSKA Sp. z.o.o. |
| 2018-12-19 | Z-0590-2019 | Class II | Orthopedic Salvage System | Zimmer Biomet, Inc. |
| 2018-12-19 | Z-0591-2019 | Class II | Comprehensive Mini Stem | Zimmer Biomet, Inc. |
| 2018-12-19 | Z-0592-2019 | Class II | IntelliVue MX40 Patient Monitor | Philips Electronics North America Corporation |
| 2018-12-19 | Z-0593-2019 | Class II | St | St. Jude Medical, Inc. |
| 2018-12-19 | Z-0594-2019 | Class II | Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE… | Helena Laboratories, Inc. |
| 2018-12-19 | Z-0595-2019 | Class II | Xcela Power Injectable PICC with PASV | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2018-12-19 | Z-0596-2019 | Class II | BioFlo PICC with ENDEXO and PASV | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2018-12-19 | Z-0597-2019 | Class II | Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch | COVIDIEN LLC |
| 2018-12-19 | Z-0598-2019 | Class II | UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift… | Neotract Inc |
| 2018-12-19 | Z-0599-2019 | Class II | AIA-2000 Analyzer | Tosoh Bioscience Inc |
| 2018-12-19 | Z-0600-2019 | Class II | AIA-900Analyzer | Tosoh Bioscience Inc |
| 2018-12-19 | Z-0601-2019 | Class III | Hemoglobin A1c Control | Tosoh Bioscience Inc |
| 2018-12-19 | Z-0602-2019 | Class II | AIA-900 Automated Immunoassay Analyzer performs three methods of… | Tosoh Bioscience Inc |
| 2018-12-19 | Z-0603-2019 | Class II | HeartStart MRx | Philips North America LLC |
| 2018-12-19 | Z-0604-2019 | Class II | Binding Site Human IgM Kit | The Binding Site Group, Ltd. |
| 2018-12-19 | Z-0605-2019 | Class II | Tritanium Posterior Lumbar | Howmedica Osteonics Corp. |
| 2018-12-19 | Z-0606-2019 | Class II | Discovery NM/CT 670 DR | GE Healthcare, LLC |
| 2018-12-19 | Z-0607-2019 | Class II | Discovery NM/CT 670 ES | GE Healthcare, LLC |
| 2018-12-19 | Z-0608-2019 | Class II | Discovery NM/CT 670 Pro | GE Healthcare, LLC |
| 2018-12-12 | Z-0463-2019 | Class I | GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard | GE Healthcare, LLC |
| 2018-12-12 | Z-0525-2019 | Class II | Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in | ASO, LLC |
| 2018-12-12 | Z-0526-2019 | Class III | NEOCONNECT | Neomed Inc |
| 2018-12-12 | Z-0527-2019 | Class II | Optional MDRC-1119 Front Cover Attachment Kit for review display… | Barco N.V. |
| 2018-12-12 | Z-0528-2019 | Class II | BD BBL Trypticase Soy Agar with 5% Sheep Blood | Becton Dickinson & Co. |
| 2018-12-12 | Z-0529-2019 | Class III | Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline… | Helena Laboratories, Inc. |
| 2018-12-12 | Z-0530-2019 | Class II | Zimmer Pressure Sentinel¿ Intramedullary Reaming System | Zimmer Biomet, Inc. |
| 2018-12-12 | Z-0531-2019 | Class II | Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire | Zimmer Biomet, Inc. |
| 2018-12-12 | Z-0532-2019 | Class II | Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire | Zimmer Biomet, Inc. |
| 2018-12-12 | Z-0533-2019 | Class II | Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire | Zimmer Biomet, Inc. |
| 2018-12-12 | Z-0534-2019 | Class II | Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire | Zimmer Biomet, Inc. |
| 2018-12-12 | Z-0535-2019 | Class II | Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire | Zimmer Biomet, Inc. |
| 2018-12-12 | Z-0536-2019 | Class II | Zimmer Humeral Guide Wire | Zimmer Biomet, Inc. |
| 2018-12-12 | Z-0537-2019 | Class II | Zimmer Smooth Guide Wire | Zimmer Biomet, Inc. |
| 2018-12-12 | Z-0538-2019 | Class II | Zimmer Natural Nail¿ System | Zimmer Biomet, Inc. |
| 2018-12-12 | Z-0539-2019 | Class II | Zimmer Natural Nail¿ System | Zimmer Biomet, Inc. |
| 2018-12-12 | Z-0540-2019 | Class II | Zimmer Natural Nail¿ System | Zimmer Biomet, Inc. |
| 2018-12-12 | Z-0541-2019 | Class II | Zimmer Natural Nail¿ System | Zimmer Biomet, Inc. |
| 2018-12-12 | Z-0542-2019 | Class II | Zimmer Pressure Sentinel¿ Intramedullary Reaming System | Zimmer Biomet, Inc. |
| 2018-12-12 | Z-0543-2019 | Class II | Brilliance 64 | Philips Medical Systems (Cleveland) Inc |
| 2018-12-12 | Z-0544-2019 | Class II | Brilliance 40 | Philips Medical Systems (Cleveland) Inc |
| 2018-12-12 | Z-0545-2019 | Class II | Brilliance 16 Slice | Philips Medical Systems (Cleveland) Inc |
| 2018-12-12 | Z-0546-2019 | Class II | Brilliance 16 Slice | Philips Medical Systems (Cleveland) Inc |
| 2018-12-12 | Z-0547-2019 | Class II | Brilliance 10 Slice | Philips Medical Systems (Cleveland) Inc |
| 2018-12-12 | Z-0548-2019 | Class II | Brilliance 6 Slice | Philips Medical Systems (Cleveland) Inc |
| 2018-12-12 | Z-0549-2019 | Class II | Invacare 9805 and 9805P Hydraulic Patient Lifts | Invacare Corporation |
| 2018-12-12 | Z-0550-2019 | Class II | Captus 3000 Thyroid Uptake System | Capintec Inc |
| 2018-12-12 | Z-0551-2019 | Class II | Captus 700 Thyroid Uptake System | Capintec Inc |
| 2018-12-12 | Z-0553-2019 | Class II | Biomet 20mm Compress Device Short Anchor Plug With Drill Set / With… | Zimmer Biomet, Inc. |
| 2018-12-12 | Z-0554-2019 | Class II | Thermacare Muscle Pain Therapy HeatWraps: a) UPC 0573301314 b) UPC… | Pfizer Inc. |
| 2018-12-12 | Z-0555-2019 | Class II | Thermacare HeatWraps Menstrual a) UPC 0573302002 b) UPC 0573302044… | Pfizer Inc. |
| 2018-12-12 | Z-0556-2019 | Class II | Thermacare HEATWRAPS JOINT PAIN THERAPY | Pfizer Inc. |
| 2018-12-12 | Z-0557-2019 | Class II | STEPHANIX D2RS Digital Dynamic Remote Systemhttp://cts | Stephanix |
| 2018-12-12 | Z-0558-2019 | Class II | Artis Zee and Zeego | Siemens Medical Solutions USA, Inc |
| 2018-12-12 | Z-0559-2019 | Class II | AIA-360 Analyzer | Tosoh Bioscience Inc |
| 2018-12-12 | Z-0560-2019 | Class II | Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE | Atrium Medical Corporation |
| 2018-12-12 | Z-0561-2019 | Class II | Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE… | Helena Laboratories, Inc. |
| 2018-12-05 | Z-0436-2019 | Class I | QUADROX-i Neonatal without integrated arterial filter and VHK 11000 | Maquet Cardiovascular Us Sales, Llc |
| 2018-12-05 | Z-0437-2019 | Class I | QUADROX-i Neonatal with integrated arterial filter and VHK 11000 | Maquet Cardiovascular Us Sales, Llc |
| 2018-12-05 | Z-0470-2019 | Class I | BrightMatter Guide | Synaptive Medical Inc |
| 2018-12-05 | Z-0498-2019 | Class II | Reprocessed Xcel Bladeless Trocar | Stryker Sustainability Solutions |
| 2018-12-05 | Z-0499-2019 | Class II | Dimension Vista Lactate Dehydrogenase | Siemens Healthcare Diagnostics, Inc. |
| 2018-12-05 | Z-0500-2019 | Class II | NxStage PureFlow B Solution-RFP-400 | NxStage Medical, Inc. |
| 2018-12-05 | Z-0501-2019 | Class II | NxStage PureFlow B Solution-RFP-401 | NxStage Medical, Inc. |
| 2018-12-05 | Z-0502-2019 | Class II | NxStage PureFlow B Solution-RFP-402 | NxStage Medical, Inc. |
| 2018-12-05 | Z-0503-2019 | Class II | NxStage PureFlow B Solution-RFP-403 | NxStage Medical, Inc. |
| 2018-12-05 | Z-0504-2019 | Class II | NxStage PureFlow B Solution-RFP-404 | NxStage Medical, Inc. |
| 2018-12-05 | Z-0505-2019 | Class II | NxStage PureFlow B Solution-RFP-406 | NxStage Medical, Inc. |
| 2018-12-05 | Z-0506-2019 | Class II | NxStage PureFlow B Solution-RFP-RFP-454 | NxStage Medical, Inc. |
| 2018-12-05 | Z-0507-2019 | Class II | NxStage PureFlow B Solution-RFP-RFP-456 | NxStage Medical, Inc. |
| 2018-12-05 | Z-0508-2019 | Class II | PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated… | WOM World of Medicine AG |
| 2018-12-05 | Z-0509-2019 | Class II | AIA-900 Automated Immunoassay Analyzer | Tosoh Bioscience Inc |
| 2018-12-05 | Z-0510-2019 | Class II | Multi-Track Angiographic Catheter | Numed Inc |
| 2018-12-05 | Z-0511-2019 | Class II | Multi-Track Angiographic Catheter | Numed Inc |
| 2018-12-05 | Z-0512-2019 | Class II | Medex High Pressure Stopcock used to control the direction of IV… | Smiths Medical ASD Inc. |
| 2018-12-05 | Z-0513-2019 | Class II | PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1 | PerkinElmer Health Sciences Canada, Inc. |
| 2018-12-05 | Z-0514-2019 | Class II | HemoTrol Level 2- In Vitro Diagnostic Hematology quality control… | EUROTROL INC |
| 2018-12-05 | Z-0515-2019 | Class II | HemoTrol Level 3- In Vitro Diagnostic Hematology quality control… | EUROTROL INC |
| 2018-12-05 | Z-0516-2019 | Class III | Fresenius Granuflo Dry Acid Concentrate- 2K 2 | Fresenius Medical Care Renal Therapies Group, LLC |
| 2018-12-05 | Z-0517-2019 | Class III | Fresenius Granuflo Dry Acid Concentrate- 2K 2 | Fresenius Medical Care Renal Therapies Group, LLC |
| 2018-12-05 | Z-0518-2019 | Class III | Fresenius Granuflo Dry Acid Concentrate- 3K 2 | Fresenius Medical Care Renal Therapies Group, LLC |
| 2018-12-05 | Z-0519-2019 | Class II | Dash 3000 Patient Monitoring System is used to monitor physiologic… | GE Healthcare, LLC |
| 2018-12-05 | Z-0520-2019 | Class II | Dash 4000 Patient Monitoring System is used to monitor physiologic… | GE Healthcare, LLC |
| 2018-12-05 | Z-0521-2019 | Class II | Dash 5000 Patient Monitoring System is used to monitor physiologic… | GE Healthcare, LLC |
| 2018-12-05 | Z-0522-2019 | Class II | Solar 8000i Patient Monitoring System is used to monitor physiologic… | GE Healthcare, LLC |
| 2018-12-05 | Z-0523-2019 | Class II | Solar 8000M Patient Monitoring System is used to monitor physiologic… | GE Healthcare, LLC |
| 2018-12-05 | Z-0524-2019 | Class II | Solar 9500 Information Monitoring System is used to monitor… | GE Healthcare, LLC |
| 2018-11-28 | Z-0388-2019 | Class II | DeltaVision OMX SR Imaging System Model Number: 29115476 The… | GE Healthcare Biosciences |
| 2018-11-28 | Z-0471-2019 | Class I | 1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC… | Beckman Coulter Inc. |
| 2018-11-28 | Z-0472-2019 | Class I | COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer… | Beckman Coulter Inc. |
| 2018-11-28 | Z-0473-2019 | Class II | LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt | LeMaitre Vascular, Inc. |
| 2018-11-28 | Z-0474-2019 | Class II | The SQ-RX Pulse Generator a component of the Subcutaneous Implantable… | Boston Scientific Corporation |
| 2018-11-28 | Z-0475-2019 | Class II | AIA-2000 Analyzer | Tosoh Bioscience Inc |
| 2018-11-28 | Z-0476-2019 | Class II | VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27 | Ortho-Clinical Diagnostics |
| 2018-11-28 | Z-0477-2019 | Class II | Binding Site Human IgM Kit | The Binding Site Group, Ltd. |
| 2018-11-28 | Z-0478-2019 | Class II | Insulia Diabetes Management Companion | Voluntis |
| 2018-11-28 | Z-0479-2019 | Class II | Giraffe OmniBed Carestation | GE Healthcare, LLC |
| 2018-11-28 | Z-0480-2019 | Class II | Giraffe Incubator Carestation | GE Healthcare, LLC |
| 2018-11-28 | Z-0481-2019 | Class II | Giraffe Warmer | GE Healthcare, LLC |
| 2018-11-28 | Z-0482-2019 | Class II | Panda iRes Infant Radiant Warmer | GE Healthcare, LLC |
| 2018-11-28 | Z-0483-2019 | Class II | Panda Freestanding Warmer | GE Healthcare, LLC |
| 2018-11-28 | Z-0484-2019 | Class II | Panda Wall Mount warmer | GE Healthcare, LLC |
| 2018-11-28 | Z-0485-2019 | Class II | Tosoh AIA-900 immunoassay Analyzer | Tosoh Bioscience Inc |
| 2018-11-28 | Z-0486-2019 | Class II | Ascom Telligence Nurse Call System | Ascom (US) Inc. |
| 2018-11-28 | Z-0487-2019 | Class II | PremierPro Aluminum Adjustable Walker | SVS LLC |
| 2018-11-28 | Z-0488-2019 | Class II | Sedecal NOVA FA DR System | Sedecal S.A. |
| 2018-11-28 | Z-0489-2019 | Class II | Minicon Clinical Sample Concentrators for In Vitro Diagnostic Use 9031 | Merck Millipore Ltd. |
| 2018-11-28 | Z-0490-2019 | Class II | Irrisept OR | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company |
| 2018-11-28 | Z-0491-2019 | Class II | BD Vacutainer Urine Collection Cups | Becton Dickinson & Company |
| 2018-11-28 | Z-0492-2019 | Class II | BD Vacutainer Specimen Collection Cups | Becton Dickinson & Company |
| 2018-11-28 | Z-0493-2019 | Class II | KIT URIN CUP PLC 16X100 10 | Becton Dickinson & Company |
| 2018-11-28 | Z-0494-2019 | Class II | KIT URIN CUP 16X100 8 | Becton Dickinson & Company |
| 2018-11-28 | Z-0495-2019 | Class II | Vanguard Knee System -PS Open Box Femoral Left | Zimmer Biomet, Inc. |
| 2018-11-28 | Z-0496-2019 | Class II | Vanguard Knee System -PS Open Box Femoral Right | Zimmer Biomet, Inc. |
| 2018-11-21 | Z-0369-2019 | Class I | GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System… | GE Healthcare, LLC |
| 2018-11-21 | Z-0370-2019 | Class I | GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector… | GE Healthcare, LLC |
| 2018-11-21 | Z-0371-2019 | Class I | GE Healthcare Millennium MC | GE Healthcare, LLC |
| 2018-11-21 | Z-0411-2019 | Class II | Aisys Anesthesia System | GE Healthcare, LLC |
| 2018-11-21 | Z-0412-2019 | Class II | Aisys CS2 Anesthesia System | GE Healthcare, LLC |
| 2018-11-21 | Z-0413-2019 | Class II | Touchscreen display kit | GE Healthcare, LLC |
| 2018-11-21 | Z-0414-2019 | Class III | BioMend Extend | Collagen Matrix, Inc. |
| 2018-11-21 | Z-0415-2019 | Class II | OviTex Reinforced BioScaffold 4x8cm | AROA Biosurgery, LTD. |