| Reported | Recall | Class | Product | Firm |
|---|
| 2022-05-04 | Z-0953-2022 | Class I | Celltrion DiaTrust COVID-19 Ag Rapid Test | CELLTRION USA INC |
| 2022-05-04 | Z-0966-2022 | Class I | Puritan Bennett 980 Series Ventilator | Medtronic formerly Covidien |
| 2022-05-04 | Z-0991-2022 | Class II | PrisMax System | Baxter Healthcare Corporation |
| 2022-05-04 | Z-0992-2022 | Class II | PrisMax System | Baxter Healthcare Corporation |
| 2022-05-04 | Z-0993-2022 | Class II | PrisMax System | Baxter Healthcare Corporation |
| 2022-05-04 | Z-0994-2022 | Class II | syngo | Siemens Medical Solutions USA, Inc |
| 2022-05-04 | Z-0995-2022 | Class II | syngo | Siemens Medical Solutions USA, Inc |
| 2022-05-04 | Z-0996-2022 | Class II | syngo | Siemens Medical Solutions USA, Inc |
| 2022-05-04 | Z-0997-2022 | Class II | syngo | Siemens Medical Solutions USA, Inc |
| 2022-05-04 | Z-0998-2022 | Class II | MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL | Medtronic Neuromodulation |
| 2022-05-04 | Z-0999-2022 | Class II | da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi… | Intuitive Surgical, Inc. |
| 2022-05-04 | Z-1000-2022 | Class II | NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular… | NeuMoDx Molecular Inc |
| 2022-05-04 | Z-1001-2022 | Class II | TearCare version 1 | Sight Sciences, Inc. |
| 2022-05-04 | Z-1002-2022 | Class II | SpaceOAR System | Boston Scientific Corporation |
| 2022-05-04 | Z-1003-2022 | Class II | SpaceOAR Vue System | Boston Scientific Corporation |
| 2022-05-04 | Z-1004-2022 | Class II | Convenience kits containing regard IV Start Kits: | ROi CPS LLC |
| 2022-05-04 | Z-1005-2022 | Class II | Convenience kits containing regard IV Start Kits: | ROi CPS LLC |
| 2022-05-04 | Z-1006-2022 | Class II | Convenience kits containing regard IV Start Kits: regard Clinical… | ROi CPS LLC |
| 2022-05-04 | Z-1007-2022 | Class II | ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000 | Carl Zeiss Meditec AG |
| 2022-05-04 | Z-1008-2022 | Class II | RocheDiabetes Care Platform Software version 2 | Roche Diabetes Care, Inc. |
| 2022-05-04 | Z-1010-2022 | Class II | Acuson 9vE4 Transducer | Siemens Medical Solutions USA, Inc. |
| 2022-05-04 | Z-1011-2022 | Class II | Smart Toe II Intramedullary Arthrodesis Implant | Stryker GmbH |
| 2022-05-04 | Z-1012-2022 | Class II | Drager Infinity CentralStation Software versions VG2 | Draegar Medical Systems, Inc. |
| 2022-05-04 | Z-1013-2022 | Class II | WAVES WCM Kidney Cassette Module | Waters Medical Systems LLC |
| 2022-05-04 | Z-1014-2022 | Class II | ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1 | Instrumentation Laboratory |
| 2022-05-04 | Z-1015-2022 | Class II | IMMULITE 2000 Systems HCG [200 Tests | Siemens Healthcare Diagnostics, Inc. |
| 2022-05-04 | Z-1016-2022 | Class II | Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model:… | Freudenberg Medical, Llc |
| 2022-05-04 | Z-1017-2022 | Class II | Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model:… | Freudenberg Medical, Llc |
| 2022-04-27 | Z-0907-2022 | Class I | Philips Respironics V60 Ventilator | Respironics California, LLC |
| 2022-04-27 | Z-0908-2022 | Class I | Philips Respironics V60 Plus Ventilator | Respironics California, LLC |
| 2022-04-27 | Z-0909-2022 | Class I | Philips Respironics V680 Ventilator | Respironics California, LLC |
| 2022-04-27 | Z-0927-2022 | Class I | Harmony Delivery Catheter System | Medtronic Inc |
| 2022-04-27 | Z-0945-2022 | Class II | Flowflex SARS-CoV-2 Antigen Rapid Test | Acon Biotech (Hangzhou) Co., Ltd. |
| 2022-04-27 | Z-0946-2022 | Class II | Virus Counter Platform with Model Name VC3100 | Sartorius Corporation |
| 2022-04-27 | Z-0947-2022 | Class II | Matrix Clinical Solution At-Home COVID-19 Test | Matrix Medical Network |
| 2022-04-27 | Z-0948-2022 | Class II | Baxter DISCPAC Syringe Tip Caps | Baxter Healthcare Corporation |
| 2022-04-27 | Z-0949-2022 | Class II | Cardiovascular Procedure Kit catalog # 76645 & 73806 | Terumo Cardiovascular Systems Corp |
| 2022-04-27 | Z-0950-2022 | Class II | Regard IV Start Kit for preparing and/or dressing a peripheral vein… | Resource Optimization & Innovation LLC |
| 2022-04-27 | Z-0951-2022 | Class II | therascreen KRAS RGQ PCR Kit | Qiagen Sciences LLC |
| 2022-04-27 | Z-0952-2022 | Class II | therascreen KRAS RGQ PCR Kit | Qiagen Sciences LLC |
| 2022-04-27 | Z-0954-2022 | Class II | Inactivated macrolide and quinolone-resistant Mycoplasma genitalium | Microbiologics Inc |
| 2022-04-27 | Z-0955-2022 | Class II | Inactivated macrolide-resistant Mycoplasma genitalium | Microbiologics Inc |
| 2022-04-27 | Z-0956-2022 | Class II | Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter | Abbott |
| 2022-04-27 | Z-0957-2022 | Class II | Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter | Abbott |
| 2022-04-27 | Z-0958-2022 | Class II | 4 | Acumed LLC |
| 2022-04-27 | Z-0959-2022 | Class II | 4 | Acumed LLC |
| 2022-04-27 | Z-0960-2022 | Class II | HUNTLEIGH Disposable intraoperative Probe | Huntleigh Healthcare Ltd. |
| 2022-04-27 | Z-0961-2022 | Class II | Software 1898072 IPC upgrade v 2 | Medtronic Xomed, Inc. |
| 2022-04-27 | Z-0962-2022 | Class II | SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go | Siemens Medical Solutions USA, Inc |
| 2022-04-27 | Z-0963-2022 | Class II | The Sight OLO device is a computer vision based platform for blood… | SIGHT DIAGNOSTICS LTD |
| 2022-04-27 | Z-0964-2022 | Class II | Merlin PCS 3650 programmer Model 3330 software | St. Jude Medical, Cardiac Rhythm Management Division |
| 2022-04-27 | Z-0965-2022 | Class II | Merlin 2 PCS MER3700 programmer Model MER3400 software | St. Jude Medical, Cardiac Rhythm Management Division |
| 2022-04-27 | Z-0967-2022 | Class II | Artis zee floor | Siemens Medical Solutions USA, Inc |
| 2022-04-27 | Z-0968-2022 | Class II | Artis zee ceiling | Siemens Medical Solutions USA, Inc |
| 2022-04-27 | Z-0969-2022 | Class II | Artis zee multi-purpose | Siemens Medical Solutions USA, Inc |
| 2022-04-27 | Z-0970-2022 | Class II | Artis zee biplane | Siemens Medical Solutions USA, Inc |
| 2022-04-27 | Z-0971-2022 | Class II | Artis zee floor MN | Siemens Medical Solutions USA, Inc |
| 2022-04-27 | Z-0972-2022 | Class II | Artis zee biplane MN | Siemens Medical Solutions USA, Inc |
| 2022-04-27 | Z-0973-2022 | Class II | Artis zeego | Siemens Medical Solutions USA, Inc |
| 2022-04-27 | Z-0974-2022 | Class II | Artis Q floor | Siemens Medical Solutions USA, Inc |
| 2022-04-27 | Z-0975-2022 | Class II | Artis Q ceiling | Siemens Medical Solutions USA, Inc |
| 2022-04-27 | Z-0976-2022 | Class II | Artis Q biplane | Siemens Medical Solutions USA, Inc |
| 2022-04-27 | Z-0977-2022 | Class II | Artis Q zeego | Siemens Medical Solutions USA, Inc |
| 2022-04-27 | Z-0978-2022 | Class II | Artis Q | Siemens Medical Solutions USA, Inc |
| 2022-04-27 | Z-0979-2022 | Class II | Artis Q | Siemens Medical Solutions USA, Inc |
| 2022-04-27 | Z-0980-2022 | Class II | Artis Q | Siemens Medical Solutions USA, Inc |
| 2022-04-27 | Z-0981-2022 | Class II | ORAcollect Dx | DNA Genotek Inc. |
| 2022-04-27 | Z-0982-2022 | Class II | ORAcollect RNA: ORE-100 | DNA Genotek Inc. |
| 2022-04-27 | Z-0983-2022 | Class II | GE Healthcare MR Systems | GE Healthcare, LLC |
| 2022-04-27 | Z-0984-2022 | Class III | Beckman Coulter IRISpec CA/CB/CC control | Beckman Coulter, Inc. |
| 2022-04-27 | Z-0985-2022 | Class II | Artis icono biplane- in combination with a Siemens Healthineers table… | Siemens Medical Solutions USA, Inc |
| 2022-04-27 | Z-0986-2022 | Class II | Artis icono floor in combination with a Siemens Healthineers table or… | Siemens Medical Solutions USA, Inc |
| 2022-04-27 | Z-0987-2022 | Class II | Artis pheno- in combination with a Siemens Healthineers table or… | Siemens Medical Solutions USA, Inc |
| 2022-04-27 | Z-0988-2022 | Class II | Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q | St. Jude Medical, Cardiac Rhythm Management Division |
| 2022-04-27 | Z-0989-2022 | Class II | Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q | St. Jude Medical, Cardiac Rhythm Management Division |
| 2022-04-27 | Z-0990-2022 | Class II | Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q | St. Jude Medical, Cardiac Rhythm Management Division |
| 2022-04-20 | Z-0872-2022 | Class II | Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis… | B Braun Medical Inc |
| 2022-04-20 | Z-0873-2022 | Class II | Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis… | B Braun Medical Inc |
| 2022-04-20 | Z-0899-2022 | Class II | iTotal Identity Posterior Stabilised | Conformis, Inc. |
| 2022-04-20 | Z-0900-2022 | Class II | LIPOSORBER System | Kaneka America Corp |
| 2022-04-20 | Z-0901-2022 | Class III | IntraSight Mobile IVUS Systems | Volcano Corp |
| 2022-04-20 | Z-0902-2022 | Class II | Cardinal Health PROTEXIS PI and PI Classic | Cardinal Health 200, LLC |
| 2022-04-20 | Z-0903-2022 | Class II | Access-9 Large Bore Hemostasis Valves | Merit Medical Systems, Inc. |
| 2022-04-20 | Z-0904-2022 | Class II | AccessPLUS Large Bore Hemostasis Valves | Merit Medical Systems, Inc. |
| 2022-04-20 | Z-0905-2022 | Class II | Separation Technology Creamatocrit Plus | Stanbio Laboratory, LP |
| 2022-04-20 | Z-0906-2022 | Class II | Integra Universal Flexible Arm part number REF 1362275 | Integra LifeSciences Corp. |
| 2022-04-20 | Z-0910-2022 | Class II | Nextra Hammertoe Correction System 4 | Nextremity Solutions |
| 2022-04-20 | Z-0911-2022 | Class II | Nextra Hammertoe Correction System 4 | Nextremity Solutions |
| 2022-04-20 | Z-0912-2022 | Class II | Nextra Hammertoe Correction System 3 | Nextremity Solutions |
| 2022-04-20 | Z-0913-2022 | Class II | Nextra Hammertoe Correction System 3 | Nextremity Solutions |
| 2022-04-20 | Z-0914-2022 | Class II | Nextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic… | Nextremity Solutions |
| 2022-04-20 | Z-0915-2022 | Class II | ROTAWIRE Drive and wireClip Torquer | Boston Scientific Corporation |
| 2022-04-20 | Z-0916-2022 | Class II | ROTAWIRE Drive and wireClip Torquer | Boston Scientific Corporation |
| 2022-04-20 | Z-0917-2022 | Class III | MM-TSM | Volcano Corp |
| 2022-04-20 | Z-0918-2022 | Class I | Cub 2 Enclosed Bed Canopy System | Sensory Medical Inc |
| 2022-04-20 | Z-0919-2022 | Class II | MUSE Cardiology Information System | GE Healthcare, LLC |
| 2022-04-20 | Z-0920-2022 | Class II | Verigene Processor SP | Luminex Corporation |
| 2022-04-20 | Z-0921-2022 | Class II | 20/30 INDEFLATOR -REF 1000184 WPL2122268-01 | Abbott Vascular |
| 2022-04-20 | Z-0922-2022 | Class II | 20/30 Priority Pack Accessory Kit/ | Abbott Vascular |
| 2022-04-20 | Z-0923-2022 | Class II | 20/30 Priority Pack w/COPILOT | Abbott Vascular |
| 2022-04-20 | Z-0924-2022 | Class II | INDEFLATOR Plus 30 | Abbott Vascular |
| 2022-04-20 | Z-0925-2022 | Class II | Plus 30 Priority Pack w/ | Abbott Vascular |
| 2022-04-20 | Z-0926-2022 | Class II | The IFU for the Autoclavable Temperature Probes: Part # 453564635891 | Philips North America, LLC |
| 2022-04-20 | Z-0928-2022 | Class II | Atellica CH Calcium_2 | Siemens Healthcare Diagnostics, Inc. |
| 2022-04-20 | Z-0929-2022 | Class II | Atellica CH Enzymatic Hemoglobin A1c | Siemens Healthcare Diagnostics, Inc. |
| 2022-04-20 | Z-0930-2022 | Class II | Atellica CH Fructosamine | Siemens Healthcare Diagnostics, Inc. |
| 2022-04-20 | Z-0931-2022 | Class II | Atellica CH Lithium_2 | Siemens Healthcare Diagnostics, Inc. |
| 2022-04-20 | Z-0932-2022 | Class II | Hydroxybutyrate LiquiColor Tests | MEDLINE INDUSTRIES, LP - Northfield |
| 2022-04-20 | Z-0933-2022 | Class II | Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards | MEDLINE INDUSTRIES, LP - Northfield |
| 2022-04-20 | Z-0934-2022 | Class II | Trumpf Mount Clamp Assembly | Deerfield Imaging, Inc. |
| 2022-04-20 | Z-0935-2022 | Class II | CLARAVUE Pre-wired Electrode IP-SET N3 | Graphic Controls Acquisition Corporation |
| 2022-04-20 | Z-0936-2022 | Class II | CLARAVUE Pre-wired Electrode | Graphic Controls Acquisition Corporation |
| 2022-04-20 | Z-0937-2022 | Class II | CLARAVUE Pre-wired Electrode | Graphic Controls Acquisition Corporation |
| 2022-04-20 | Z-0938-2022 | Class II | CLARAVUE Pre-wired Electrode | Graphic Controls Acquisition Corporation |
| 2022-04-20 | Z-0939-2022 | Class II | CLARAVUE Pre-wired Electrode | Graphic Controls Acquisition Corporation |
| 2022-04-20 | Z-0940-2022 | Class II | CLARAVUE Pre-wired Electrode | Graphic Controls Acquisition Corporation |
| 2022-04-20 | Z-0941-2022 | Class II | Medline Standard PVC Laryngeal Masks | MEDLINE INDUSTRIES, LP - Northfield |
| 2022-04-20 | Z-0942-2022 | Class II | ARIA Radiation Therapy Management | Varian Medical Systems Imaging Laboratory GmbH |
| 2022-04-20 | Z-0943-2022 | Class II | Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS… | Breas Medical, Inc. |
| 2022-04-13 | Z-0730-2022 | Class II | YSIO X | Siemens Medical Solutions USA, Inc |
| 2022-04-13 | Z-0737-2022 | Class II | Philips StentBoost Live R2 | Philips Healthcare |
| 2022-04-13 | Z-0815-2022 | Class II | Revolution Apex | GE Healthcare, LLC |
| 2022-04-13 | Z-0816-2022 | Class II | Revolution CT | GE Healthcare, LLC |
| 2022-04-13 | Z-0856-2022 | Class II | Silatrix Oral Gel Polymerized Sucralfate Gel 10% | SA3, LLC |
| 2022-04-13 | Z-0857-2022 | Class II | Signa 1 | GE Healthcare, LLC |
| 2022-04-13 | Z-0858-2022 | Class II | 1 | GE Healthcare, LLC |
| 2022-04-13 | Z-0859-2022 | Class II | SIGNA Excite 3T | GE Healthcare, LLC |
| 2022-04-13 | Z-0860-2022 | Class II | 1 | GE Healthcare, LLC |
| 2022-04-13 | Z-0861-2022 | Class II | Tempus LS | Remote Diagnostic Technologies Ltd. |
| 2022-04-13 | Z-0862-2022 | Class II | Surgicare Neuro Pack | Stradis Medical, LLC dba Stradis Healthcare |
| 2022-04-13 | Z-0863-2022 | Class II | Lum Lam Custom Pack | Stradis Medical, LLC dba Stradis Healthcare |
| 2022-04-13 | Z-0864-2022 | Class II | Total Knee Pack | Stradis Medical, LLC dba Stradis Healthcare |
| 2022-04-13 | Z-0865-2022 | Class II | Anterior Hip Pack | Stradis Medical, LLC dba Stradis Healthcare |
| 2022-04-13 | Z-0866-2022 | Class II | Coryell Memorial Hosp Total | Stradis Medical, LLC dba Stradis Healthcare |
| 2022-04-13 | Z-0867-2022 | Class II | MODEL: X-RAY R/F SYSTEM FLUOROspeed X1 | Shimadzu Medical Systems |
| 2022-04-13 | Z-0868-2022 | Class II | MODEL: X-RAY TV SYSTEM SONIALVISION G4 | Shimadzu Medical Systems |
| 2022-04-13 | Z-0869-2022 | Class II | MODEL: X-RAY TV SYSSTEM SONIALVISION safire17 | Shimadzu Medical Systems |
| 2022-04-13 | Z-0870-2022 | Class II | Evita V500 Ventilator with Software 2 | Draeger Medical, Inc. |
| 2022-04-13 | Z-0871-2022 | Class II | Babylog VN500 Ventilator with Software 2 | Draeger Medical, Inc. |
| 2022-04-13 | Z-0874-2022 | Class II | Philips Allura | Philips North America Llc |
| 2022-04-13 | Z-0875-2022 | Class III | Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog… | Cook Medical Incorporated |
| 2022-04-13 | Z-0876-2022 | Class III | Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN:… | Cook Medical Incorporated |
| 2022-04-13 | Z-0877-2022 | Class II | Panther Fusion GBS Assay Cartridges 96 Tests | Hologic, Inc |
| 2022-04-13 | Z-0878-2022 | Class II | DeRoyal ST Neonatal Dressing Change Kit | DeRoyal Industries Inc |
| 2022-04-13 | Z-0879-2022 | Class II | DeRoyal Ultra/Mammo Tray | DeRoyal Industries Inc |
| 2022-04-13 | Z-0880-2022 | Class II | DeRoyal DEXMED ACCESS CENTER TRAY | DeRoyal Industries Inc |
| 2022-04-13 | Z-0881-2022 | Class II | Philips | Philips North America LLC |
| 2022-04-13 | Z-0882-2022 | Class II | Philips | Philips North America LLC |
| 2022-04-13 | Z-0883-2022 | Class II | Alinity m HBV Application Specification File | Abbott Molecular, Inc. |
| 2022-04-13 | Z-0884-2022 | Class II | Alinity m HBV AMP Kit | Abbott Molecular, Inc. |
| 2022-04-13 | Z-0885-2022 | Class II | SyncVision Systems | Volcano Corporation |
| 2022-04-13 | Z-0887-2022 | Class II | Ultima Activator II Reusable Drive Mechanism | Maquet Cardiovascular, LLC |
| 2022-04-13 | Z-0888-2022 | Class II | Brius Pontics | Brius Technologies Inc. |
| 2022-04-13 | Z-0889-2022 | Class II | Brius Patient Specific Brackets | Brius Technologies Inc. |
| 2022-04-13 | Z-0890-2022 | Class II | Customized Brius Appliances | Brius Technologies Inc. |
| 2022-04-13 | Z-0891-2022 | Class II | ARCHITECT STAT Myoglobin Calibrators | Abbott Laboratories |
| 2022-04-13 | Z-0892-2022 | Class II | First SIGN SARS-CoV-2 Antigen Test | WHPM Inc. |
| 2022-04-13 | Z-0893-2022 | Class II | Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems | Siemens Medical Solutions USA, Inc. |
| 2022-04-13 | Z-0894-2022 | Class II | BenchMark ULTRA and DISCOVERY ULTRA Instruments | Ventana Medical Systems Inc |
| 2022-04-13 | Z-0895-2022 | Class II | Amplatzer Steerable Delivery Sheath | Abbott |
| 2022-04-13 | Z-0896-2022 | Class II | C-Peptide ELISA : IVD measurement of C-Peptide in serum | DRG International, Inc. |
| 2022-04-13 | Z-0897-2022 | Class II | Cardiohelp-i Transport Guard with Transport Guard | Maquet Medical Systems USA |
| 2022-04-13 | Z-0898-2022 | Class II | Excelsior Medical 10mL Sterile Field Saline Flush ZR | MEDLINE INDUSTRIES, LP - Northfield |
| 2022-04-06 | Z-0826-2022 | Class II | CARA | Diagnos Inc |
| 2022-04-06 | Z-0827-2022 | Class II | Mevion S250 and S250i Proton Therapy Systems hand pendant | Mevion Medical Systems, Inc. |
| 2022-04-06 | Z-0828-2022 | Class II | cobas LiatSystem | Roche Molecular Systems, Inc. |
| 2022-04-06 | Z-0829-2022 | Class II | Liko Universal Twinbar 670 QRH | Baxter Healthcare Corporation |
| 2022-04-06 | Z-0830-2022 | Class II | Siemens Dimension Vista Magnesium Flex reagent cartridge | Siemens Healthcare Diagnostics, Inc. |
| 2022-04-06 | Z-0831-2022 | Class II | MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S | Baxter Healthcare Corporation |
| 2022-04-06 | Z-0832-2022 | Class II | Nimbus PainPro Ambulatory Infusion Pumps with software version v4 | InfuTronix LLC |
| 2022-04-06 | Z-0833-2022 | Class II | (a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm,… | Carefusion 2200 Inc |
| 2022-04-06 | Z-0834-2022 | Class II | FORE-SIGHT ELITE Absolute Tissue Oximeter | Edwards Lifesciences, LLC |
| 2022-04-06 | Z-0835-2022 | Class II | FORE-SIGHT ELITE Tissue Oximeter module | Edwards Lifesciences, LLC |
| 2022-04-06 | Z-0836-2022 | Class II | Revogene | Meridian Bioscience Inc |
| 2022-04-06 | Z-0837-2022 | Class III | Regard Custom Procedure Kits containing BD Luer Lok Access Devices | ROi CPS LLC |
| 2022-04-06 | Z-0838-2022 | Class II | Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology… | Ansell Healthcare Products LLC |
| 2022-04-06 | Z-0841-2022 | Class II | Ysiosystem with VC10 software version | Siemens Medical Solutions USA, Inc |
| 2022-04-06 | Z-0842-2022 | Class II | Biolox delta Ceramic V40 Femoral Head 32/ -4 | Howmedica Osteonics Corp. |
| 2022-04-06 | Z-0843-2022 | Class II | Biolox delta Ceramic V40 Femoral Head 32/ +4 | Howmedica Osteonics Corp. |
| 2022-04-06 | Z-0844-2022 | Class II | Pneumonia | Microbiologics Inc |
| 2022-04-06 | Z-0845-2022 | Class II | BALLARD* Seal Cassette Replacement MAP | Avanos Medical, Inc. |
| 2022-04-06 | Z-0846-2022 | Class II | BALLARD* Multi-Access Port Catheter | Avanos Medical, Inc. |
| 2022-04-06 | Z-0847-2022 | Class II | BALLARD* Multi-Access Port | Avanos Medical, Inc. |
| 2022-04-06 | Z-0848-2022 | Class II | TomoHelical and TomoDirect plans in RayStation 6 | RAYSEARCH LABORATORIES AB |
| 2022-04-06 | Z-0849-2022 | Class II | RayStation/RayPlan versions 4 | RAYSEARCH LABORATORIES AB |
| 2022-04-06 | Z-0850-2022 | Class II | RayStation 4-11B | RaySearch America Inc |
| 2022-04-06 | Z-0851-2022 | Class II | Hanger-Bar 2P 45cm | Human Care USA, Inc. |
| 2022-04-06 | Z-0852-2022 | Class II | Hanger-Bar 2P 45cm | Human Care USA, Inc. |
| 2022-04-06 | Z-0853-2022 | Class II | EasyFuse Dynamic Compression System Instrument Pack | Wright Medical Technology, Inc. |
| 2022-04-06 | Z-0854-2022 | Class II | Illumina NextSeq 550Dx | Illumina, Inc. |
| 2022-04-06 | Z-0855-2022 | Class II | MiniMed 630G: MMT-1715 | Medtronic MiniMed |
| 2022-03-30 | Z-0734-2022 | Class II | Azurion systems with software release R2 | Philips Healthcare |
| 2022-03-30 | Z-0785-2022 | Class I | Trilogy 100 | Philips Respironics, Inc. |
| 2022-03-30 | Z-0809-2022 | Class II | BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371 | Biomet, Inc. |
| 2022-03-30 | Z-0810-2022 | Class II | BIOMET Trauma | Biomet, Inc. |
| 2022-03-30 | Z-0811-2022 | Class II | BIOMET TRAUMA A | Biomet, Inc. |
| 2022-03-30 | Z-0812-2022 | Class II | BIOMET TRAUMA Drill Bit | Biomet, Inc. |
| 2022-03-30 | Z-0813-2022 | Class II | Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000 | Outset Medical, Inc. |
| 2022-03-30 | Z-0814-2022 | Class III | TCL1 Breakapart Probe | Cytocell Ltd. |
| 2022-03-30 | Z-0817-2022 | Class II | Codman Cranial Access Kits- indicated when a craniotomy is required… | Integra LifeSciences Corp. |