| Reported | Recall | Class | Product | Firm |
|---|
| 2021-12-29 | Z-0383-2022 | Class I | Stealthstation System w/ Stealthstation Cranial Software 3 | Medtronic Navigation, Inc. |
| 2021-12-29 | Z-0392-2022 | Class II | Stryker CLAW II ORTHOLOC 3DSi Plate | Wright Medical Technology Inc |
| 2021-12-29 | Z-0393-2022 | Class II | Stryker DARCO Screw | Wright Medical Technology Inc |
| 2021-12-29 | Z-0394-2022 | Class I | WIRION EMBOLIC PROTECTION SYSTEM | Cardiovascular Systems Inc |
| 2021-12-29 | Z-0395-2022 | Class II | VirtuTRAX Instrument Navigator | Civco Medical Instruments Co. Inc. |
| 2021-12-29 | Z-0396-2022 | Class II | VirtuTRAX Instrument Navigator | Civco Medical Instruments Co. Inc. |
| 2021-12-29 | Z-0397-2022 | Class II | VirtuTRAX Instrument Navigator | Civco Medical Instruments Co. Inc. |
| 2021-12-29 | Z-0398-2022 | Class II | VirtuTRAX Instrument Navigator | Civco Medical Instruments Co. Inc. |
| 2021-12-29 | Z-0399-2022 | Class II | SYNCHRON Systems Cholesterol | Beckman Coulter Inc. |
| 2021-12-29 | Z-0400-2022 | Class II | Custom Assemblies | Stradis Medical, LLC dba Stradis Healthcare |
| 2021-12-29 | Z-0401-2022 | Class II | Wright Medical Technology Inc | Wright Medical Technology, Inc. |
| 2021-12-29 | Z-0402-2022 | Class II | These are communication systems | Hill-Rom Inc. |
| 2021-12-29 | Z-0403-2022 | Class II | Hemashield Gold Knitted Bifurcated | Maquet Cardiovascular, LLC |
| 2021-12-29 | Z-0404-2022 | Class II | Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls | MEDLINE INDUSTRIES, LP - Northfield |
| 2021-12-29 | Z-0405-2022 | Class II | Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used… | Beaver Visitec International, Inc. |
| 2021-12-29 | Z-0406-2022 | Class II | Malosa Core Suface Treatment Pack -Medical Corneal Kit intended to be… | Beaver Visitec International, Inc. |
| 2021-12-29 | Z-0407-2022 | Class II | Malosa Core Phaco Pack 1-Medical Cataract Kit intended to be used to… | Beaver Visitec International, Inc. |
| 2021-12-29 | Z-0408-2022 | Class II | Malosa Core Phaco Pack 2- Medical Refractive Kit intended to be used… | Beaver Visitec International, Inc. |
| 2021-12-29 | Z-0409-2022 | Class II | Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used… | Beaver Visitec International, Inc. |
| 2021-12-29 | Z-0410-2022 | Class II | Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Refractive Kit… | Beaver Visitec International, Inc. |
| 2021-12-29 | Z-0411-2022 | Class II | regard Clinical Packaging Solutions Item Number 830096005 | ROi CPS LLC |
| 2021-12-29 | Z-0412-2022 | Class II | Leica Microsystems M220 F12 Microscope Systems | Leica Microsystems, Inc. |
| 2021-12-29 | Z-0413-2022 | Class II | Torosa Saline-Filled Testicular Prosthesis | Coloplast Manufacturing US, LLC |
| 2021-12-29 | Z-0414-2022 | Class II | Skinny Needle with Chiba Tip | Cook Inc. |
| 2021-12-29 | Z-0415-2022 | Class II | TruDi NAV Suction Instruments: 0-Degree | Acclarent, Inc. |
| 2021-12-29 | Z-0416-2022 | Class II | Philips Allura Xper FD series with Software Version Number: 2 | Philips North America Llc |
| 2021-12-29 | Z-0417-2022 | Class II | Stealth Autoguide Tracker | Medtronic Navigation, Inc. |
| 2021-12-22 | Z-0336-2022 | Class I | Cardiosave Hybrid IntraAortic Balloon Pump | Datascope Corp. |
| 2021-12-22 | Z-0337-2022 | Class I | Cardiosave Rescue IntraAortic Balloon Pump | Datascope Corp. |
| 2021-12-22 | Z-0358-2022 | Class II | EVLP Convenience Pack/Kit | Medline Industries Inc |
| 2021-12-22 | Z-0359-2022 | Class II | Neuro Convenience Kit | Medline Industries Inc |
| 2021-12-22 | Z-0360-2022 | Class II | Major Vascular CDS Convenience Kit | Medline Industries Inc |
| 2021-12-22 | Z-0361-2022 | Class II | Venous Access Pack-LF Convenience Kit | Medline Industries Inc |
| 2021-12-22 | Z-0362-2022 | Class II | Bedside PICC CDS Convenience Kit | Medline Industries Inc |
| 2021-12-22 | Z-0363-2022 | Class II | smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE | Smith & Nephew, Inc. |
| 2021-12-22 | Z-0364-2022 | Class II | smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE | Smith & Nephew, Inc. |
| 2021-12-22 | Z-0365-2022 | Class II | smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE | Smith & Nephew, Inc. |
| 2021-12-22 | Z-0366-2022 | Class II | smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE | Smith & Nephew, Inc. |
| 2021-12-22 | Z-0367-2022 | Class II | MENTOR Saline-Filled Breast Implants are constructed from room… | Mentor Texas, LP. |
| 2021-12-22 | Z-0368-2022 | Class II | SmartGown Breathable Surgical Gowns with raglan sleeves X-large | Cardinal Health |
| 2021-12-22 | Z-0369-2022 | Class II | SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large… | Cardinal Health |
| 2021-12-22 | Z-0370-2022 | Class II | SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large… | Cardinal Health |
| 2021-12-22 | Z-0371-2022 | Class II | SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large | Cardinal Health |
| 2021-12-22 | Z-0372-2022 | Class II | Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010 | Cardinal Health |
| 2021-12-22 | Z-0373-2022 | Class II | Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040 | Cardinal Health |
| 2021-12-22 | Z-0374-2022 | Class II | Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070 | Cardinal Health |
| 2021-12-22 | Z-0375-2022 | Class II | RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518 | Cardinal Health |
| 2021-12-22 | Z-0376-2022 | Class II | RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548 | Cardinal Health |
| 2021-12-22 | Z-0377-2022 | Class II | RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578 | Cardinal Health |
| 2021-12-22 | Z-0378-2022 | Class II | RoyalSilk Non-Reinforced Surgical Gowns XXX-large | Cardinal Health |
| 2021-12-22 | Z-0379-2022 | Class II | EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number:… | Olympus Corporation of the Americas |
| 2021-12-22 | Z-0380-2022 | Class II | Miami J Select Collar | Ossur Americas |
| 2021-12-22 | Z-0381-2022 | Class II | Boston Scientific ROTAPRO | Boston Scientific Corporation |
| 2021-12-22 | Z-0382-2022 | Class II | Bartels Legionella Urinary Antigen- an adjunct to culture for the… | Clark Laboratories, Inc. |
| 2021-12-22 | Z-0384-2022 | Class II | BioGlue Surgical Adhesive | CryoLife, Inc. |
| 2021-12-22 | Z-0385-2022 | Class II | Box Label: activ5 TINY GYM IN YOUR POCKET activbody Model: Activ5… | Activbody, Inc. |
| 2021-12-22 | Z-0386-2022 | Class II | activforce 2 package labeling: Model: Activ5-M R 201-200563 | Activbody, Inc. |
| 2021-12-22 | Z-0387-2022 | Class II | Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6 | Cook Inc. |
| 2021-12-22 | Z-0388-2022 | Class II | Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7 | Cook Inc. |
| 2021-12-22 | Z-0389-2022 | Class II | Treatment applicator for Gulmay Medical 150 or Xstrahl 150… | Xstrahl Limited |
| 2021-12-22 | Z-0390-2022 | Class II | Medical Device Identification Cards associated with Sprint Quattro… | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2021-12-22 | Z-0391-2022 | Class II | Medical Device Identification Cards associated with Astra XT DR… | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2021-12-15 | Z-0332-2022 | Class II | Covidien Sonicision Battery Charger-intended to charge the Sonicision… | Covidien Llc |
| 2021-12-15 | Z-0333-2022 | Class II | Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter | Northgate Technologies, Inc. |
| 2021-12-15 | Z-0334-2022 | Class II | O3D ORCHESTRATE Orthodontic Technologies User Manual and Data… | Orchestrate Orthodontic Technologies, Inc. |
| 2021-12-15 | Z-0335-2022 | Class II | OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console… | Osteomed, LLC |
| 2021-12-15 | Z-0338-2022 | Class I | Puritan Bennett 980 Series Ventilator | Covidien Llc |
| 2021-12-15 | Z-0339-2022 | Class I | Puritan Bennett 980 Series Ventilator | Covidien Llc |
| 2021-12-15 | Z-0340-2022 | Class I | Puritan Bennett 980 Series Ventilator | Covidien Llc |
| 2021-12-15 | Z-0341-2022 | Class I | Puritan Bennett 980 Series Ventilator | Covidien Llc |
| 2021-12-15 | Z-0342-2022 | Class I | Puritan Bennett 980 Series Ventilator | Covidien Llc |
| 2021-12-15 | Z-0343-2022 | Class I | Puritan Bennett 980 Series Ventilator | Covidien Llc |
| 2021-12-15 | Z-0344-2022 | Class I | Puritan Bennett 980 Series Ventilator | Covidien Llc |
| 2021-12-15 | Z-0345-2022 | Class I | Puritan Bennett 980 Series Ventilator | Covidien Llc |
| 2021-12-15 | Z-0346-2022 | Class I | Puritan Bennett 980 Series Ventilator | Covidien Llc |
| 2021-12-15 | Z-0347-2022 | Class I | Puritan Bennett 980 Series Ventilator | Covidien Llc |
| 2021-12-15 | Z-0348-2022 | Class I | Puritan Bennett 980 Series Ventilator | Covidien Llc |
| 2021-12-15 | Z-0349-2022 | Class I | Puritan Bennett 980 Series Ventilator | Covidien Llc |
| 2021-12-15 | Z-0350-2022 | Class I | Puritan Bennett 980 Series Ventilator | Covidien Llc |
| 2021-12-15 | Z-0351-2022 | Class I | Puritan Bennett 980 Series Ventilator | Covidien Llc |
| 2021-12-15 | Z-0352-2022 | Class I | Puritan Bennett 980 Series Ventilator | Covidien Llc |
| 2021-12-15 | Z-0353-2022 | Class I | Puritan Bennett 980 Series Ventilator | Covidien Llc |
| 2021-12-15 | Z-0354-2022 | Class II | SuperCore Biopsy Instrument: REF/Product Description:… | Argon Medical Devices, Inc |
| 2021-12-15 | Z-0355-2022 | Class II | BV Endura with Software Release 2 | Philips North America Llc |
| 2021-12-15 | Z-0356-2022 | Class II | BV Pulsera with Software Release 2 | Philips North America Llc |
| 2021-12-15 | Z-0357-2022 | Class II | Veradius Unity with Software Release 2 | Philips North America Llc |
| 2021-12-08 | Z-0246-2022 | Class II | The product is a handheld ultraviolet-C germicidal wand and contains… | MAX LUX CORP |
| 2021-12-08 | Z-0308-2022 | Class II | Abbott HeartMate Touch Communication System | Thoratec Corp. |
| 2021-12-08 | Z-0309-2022 | Class II | NuStat 8" x12" Trauma Pad XR Hemafiber | Beeken Biomedical, LLC |
| 2021-12-08 | Z-0310-2022 | Class II | Total Thyroxine | DRG International, Inc. |
| 2021-12-08 | Z-0311-2022 | Class III | SHIP KIT | Cardiac Assist, Inc |
| 2021-12-08 | Z-0312-2022 | Class II | BioFire Blood Culture Identification 2 | BioFire Diagnostics, LLC |
| 2021-12-08 | Z-0313-2022 | Class II | 28MM -4 LFIT V40 HEAD | Howmedica Osteonics Corp. |
| 2021-12-08 | Z-0314-2022 | Class II | 28MM -4 LFIT V40 HEAD | Howmedica Osteonics Corp. |
| 2021-12-08 | Z-0315-2022 | Class II | INBONE Total Ankle System | Wright Medical Technology Inc |
| 2021-12-08 | Z-0316-2022 | Class II | INBONE Total Ankle System | Wright Medical Technology Inc |
| 2021-12-08 | Z-0317-2022 | Class II | HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES | O&M HALYARD INC |
| 2021-12-08 | Z-0318-2022 | Class II | The Steripath Gen2 Blood Collection System Model Number/Description… | Magnolia Medical Technologies, Inc. |
| 2021-12-08 | Z-0319-2022 | Class II | NUVASIVE PRECICE Intramedullary Limb Lengthening | NuVasive Specialized Orthopedics, Inc. |
| 2021-12-08 | Z-0320-2022 | Class II | HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of… | Boston Scientific Corporation |
| 2021-12-08 | Z-0321-2022 | Class II | HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of… | Boston Scientific Corporation |
| 2021-12-08 | Z-0322-2022 | Class II | HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of… | Boston Scientific Corporation |
| 2021-12-08 | Z-0323-2022 | Class II | HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of… | Boston Scientific Corporation |
| 2021-12-08 | Z-0324-2022 | Class II | HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of… | Boston Scientific Corporation |
| 2021-12-08 | Z-0325-2022 | Class II | HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of… | Boston Scientific Corporation |
| 2021-12-08 | Z-0326-2022 | Class II | HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of… | Boston Scientific Corporation |
| 2021-12-08 | Z-0327-2022 | Class II | HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of… | Boston Scientific Corporation |
| 2021-12-08 | Z-0328-2022 | Class II | RANDOX CHOL-cholesterol | Randox Laboratories Ltd. |
| 2021-12-08 | Z-0329-2022 | Class II | GE Centricity Universal Viewer Zero Footprint Client | GE Healthcare, LLC |
| 2021-12-08 | Z-0330-2022 | Class II | Dimension Vista 1500 In-vitro diagnostic device intended to duplicate… | Siemens Healthcare Diagnostics, Inc. |
| 2021-12-08 | Z-0331-2022 | Class II | Dimension Vista 500- In-vitro diagnostic device intended to duplicate… | Siemens Healthcare Diagnostics, Inc. |
| 2021-12-01 | Z-0238-2022 | Class II | Philips Azurion systems with software releases 2 | Philips Healthcare |
| 2021-12-01 | Z-0239-2022 | Class II | DigitalDiagnost C90 | Philips Healthcare |
| 2021-12-01 | Z-0240-2022 | Class II | ProxiDiagnost N90 is multi-functional general R/F systems | Philips Healthcare |
| 2021-12-01 | Z-0241-2022 | Class II | CombiDiagnost R90 is multi-functional general R/F systems | Philips Healthcare |
| 2021-12-01 | Z-0242-2022 | Class II | Computed Tomography Systems Revolution CT | GE Healthcare, LLC |
| 2021-12-01 | Z-0267-2022 | Class II | Roberts Digital VIPR System | Western/Scott Fetzer Company |
| 2021-12-01 | Z-0268-2022 | Class II | Western Oxytote DTE Digital VIPR | Western/Scott Fetzer Company |
| 2021-12-01 | Z-0269-2022 | Class II | Western Oxytote DTE Digital VIPR System | Western/Scott Fetzer Company |
| 2021-12-01 | Z-0270-2022 | Class II | Western Oxytote DTE Digital VIPR System | Western/Scott Fetzer Company |
| 2021-12-01 | Z-0271-2022 | Class II | ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87 | Abbott Laboratories |
| 2021-12-01 | Z-0272-2022 | Class II | ARCHITECT c4000 REF 02P24-01/2P24 | Abbott Laboratories |
| 2021-12-01 | Z-0273-2022 | Class II | Cardioblate CryoFlex Surgical Ablation Console | Medtronic Perfusion Systems |
| 2021-12-01 | Z-0274-2022 | Class II | Freelite Human Lambda Free Kit | The Binding Site Group, Ltd. |
| 2021-12-01 | Z-0275-2022 | Class II | The da Vinci Xi and X surgical systems | Intuitive Surgical, Inc. |
| 2021-12-01 | Z-0276-2022 | Class II | HemosIL ReadiPlasTin | Instrumentation Laboratory |
| 2021-12-01 | Z-0277-2022 | Class II | Continuous CT Fluoroscopy DVI Ceiling Mount | Philips North America Llc |
| 2021-12-01 | Z-0278-2022 | Class II | Continuous CT Fluoroscopy DVI Ceiling Mount | Philips North America Llc |
| 2021-12-01 | Z-0279-2022 | Class II | Continuous CT Fluoroscopy DVI Ceiling Mount | Philips North America Llc |
| 2021-12-01 | Z-0280-2022 | Class II | Continuous CT Fluoroscopy DVI Ceiling Mount | Philips North America Llc |
| 2021-12-01 | Z-0281-2022 | Class II | Continuous CT Fluoroscopy DVI Ceiling Mount | Philips North America Llc |
| 2021-12-01 | Z-0282-2022 | Class II | Medtronic CareLink SmartSync Device Manager application software | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2021-12-01 | Z-0283-2022 | Class II | SOMATOM Force with software syngo | Siemens Medical Solutions USA, Inc |
| 2021-12-01 | Z-0284-2022 | Class II | SOMATOM Definition AS with software syngo | Siemens Medical Solutions USA, Inc |
| 2021-12-01 | Z-0285-2022 | Class II | SOMATOM Definition Edge with software syngo | Siemens Medical Solutions USA, Inc |
| 2021-12-01 | Z-0286-2022 | Class II | SOMATOM Definition Flash with software syngo | Siemens Medical Solutions USA, Inc |
| 2021-12-01 | Z-0287-2022 | Class II | SOMATOM Drive with software syngo | Siemens Medical Solutions USA, Inc |
| 2021-12-01 | Z-0288-2022 | Class II | SOMATOM Confidence with software syngo | Siemens Medical Solutions USA, Inc |
| 2021-12-01 | Z-0289-2022 | Class II | SOMATOM Edge Plus with software syngo | Siemens Medical Solutions USA, Inc |
| 2021-12-01 | Z-0290-2022 | Class II | Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT… | Medtronic Vascular, Inc. |
| 2021-12-01 | Z-0291-2022 | Class II | Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT… | Medtronic Vascular, Inc. |
| 2021-12-01 | Z-0292-2022 | Class II | Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT… | Medtronic Vascular, Inc. |
| 2021-12-01 | Z-0293-2022 | Class II | Medtronic Wireless Recharger Model WR9220 included in the RS5200… | Medtronic Neuromodulation |
| 2021-12-01 | Z-0294-2022 | Class II | Medtronic Wireless Recharger Model WR9200 included in the RS6200… | Medtronic Neuromodulation |
| 2021-12-01 | Z-0295-2022 | Class II | Medtronic Wireless Recharger Model WR9200 included in the RS7200… | Medtronic Neuromodulation |
| 2021-12-01 | Z-0296-2022 | Class II | Artis zee floor with software VD12-angiography systems developed for… | Siemens Medical Solutions USA, Inc |
| 2021-12-01 | Z-0297-2022 | Class II | Artis zee ceiling with software VD12-angiography systems developed… | Siemens Medical Solutions USA, Inc |
| 2021-12-01 | Z-0298-2022 | Class II | Artis zee multi-purpose with software VD12-angiography systems… | Siemens Medical Solutions USA, Inc |
| 2021-12-01 | Z-0299-2022 | Class II | Artis zee biplane with software VD12-angiography systems developed… | Siemens Medical Solutions USA, Inc |
| 2021-12-01 | Z-0300-2022 | Class II | Artis Q floor with software VD12- angiography systems developed for… | Siemens Medical Solutions USA, Inc |
| 2021-12-01 | Z-0301-2022 | Class II | Artis Q ceiling with software VD12-angiography systems developed for… | Siemens Medical Solutions USA, Inc |
| 2021-12-01 | Z-0302-2022 | Class II | Artis Q biplane with software VD12-angiography systems developed for… | Siemens Medical Solutions USA, Inc |
| 2021-12-01 | Z-0303-2022 | Class II | Artis Q | Siemens Medical Solutions USA, Inc |
| 2021-12-01 | Z-0304-2022 | Class II | Artis Q | Siemens Medical Solutions USA, Inc |
| 2021-12-01 | Z-0305-2022 | Class II | Artis Q | Siemens Medical Solutions USA, Inc |
| 2021-12-01 | Z-0306-2022 | Class II | BD Nexiva | Becton Dickinson Infusion Therapy Systems Inc. |
| 2021-12-01 | Z-0307-2022 | Class II | The Ocean Water Seal Chest Drain is a plastic | Atrium Medical Corporation |
| 2021-11-24 | Z-0216-2022 | Class II | SMART FLEX 9x60 BIL | Cordis Corporation |
| 2021-11-24 | Z-0217-2022 | Class II | SMART FLEX 6x120 BIL | Cordis Corporation |
| 2021-11-24 | Z-0218-2022 | Class II | SMART FLEX 6x150 BIL | Cordis Corporation |
| 2021-11-24 | Z-0219-2022 | Class II | SMART FLEX 8x60 BIL | Cordis Corporation |
| 2021-11-24 | Z-0220-2022 | Class II | SMART FLEX 10x100 BIL | Cordis Corporation |
| 2021-11-24 | Z-0221-2022 | Class II | SMART FLEX 10x100 BIL | Cordis Corporation |
| 2021-11-24 | Z-0222-2022 | Class II | Transseptal Needle | Cook Inc. |
| 2021-11-24 | Z-0223-2022 | Class II | Transseptal Needle with Catheter | Cook Inc. |
| 2021-11-24 | Z-0224-2022 | Class I | Scrip Ultrasound Gel Clear | Scrip Inc |
| 2021-11-24 | Z-0225-2022 | Class I | Scrip Creme All Purpose Lotion Intended for use in acoustic coupling… | Scrip Inc |
| 2021-11-24 | Z-0226-2022 | Class II | Sensis/ Sensis Vibe systems with software VD1X as follows: | Siemens Medical Solutions USA, Inc |
| 2021-11-24 | Z-0227-2022 | Class II | Beaver Xstar Crescent Knife | Beaver Visitec International, Inc. |
| 2021-11-24 | Z-0228-2022 | Class II | bvi CustomEyes Kit-AMO Germany GmbH Katarakt-set | Beaver Visitec International, Inc. |
| 2021-11-24 | Z-0229-2022 | Class II | bvi CustomEyes Kit-Lafayette General Medical Center: CustomEyes… | Beaver Visitec International, Inc. |
| 2021-11-24 | Z-0230-2022 | Class II | bvi CustomEyes Kit-CustomEyes Cataract Surgical Kits that contain… | Beaver Visitec International, Inc. |
| 2021-11-24 | Z-0231-2022 | Class I | Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic… | Arrow International Inc |
| 2021-11-24 | Z-0232-2022 | Class I | Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic… | Arrow International Inc |
| 2021-11-24 | Z-0233-2022 | Class I | Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic… | Arrow International Inc |
| 2021-11-24 | Z-0234-2022 | Class I | Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic… | Arrow International Inc |
| 2021-11-24 | Z-0235-2022 | Class II | BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR… | Bio-Rad Laboratories, Inc. |
| 2021-11-24 | Z-0236-2022 | Class II | BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set… | Bio-Rad Laboratories, Inc. |
| 2021-11-24 | Z-0237-2022 | Class II | OMNI K2 Hip Stem | OmniLife Science |
| 2021-11-24 | Z-0243-2022 | Class II | API 50 CH | bioMerieux, Inc. |
| 2021-11-24 | Z-0244-2022 | Class II | Torque Limiting Adaptor | Laboratoires Bodycad, Inc. |
| 2021-11-24 | Z-0245-2022 | Class II | Ilizarov Wire Tensioner | Medicalplastic S.R.L. |
| 2021-11-24 | Z-0247-2022 | Class III | VITROS Immunodiagnostic Products Anti-HBc IgM Controls | Ortho-Clinical Diagnostics, Inc. |
| 2021-11-24 | Z-0248-2022 | Class II | Vit Kit-Freeze is intended for use in assisted reproductive… | Fujifilm Irvine Scientific, Inc. |
| 2021-11-24 | Z-0249-2022 | Class II | Vit Kit-Freeze is intended for use in assisted reproductive… | Fujifilm Irvine Scientific, Inc. |
| 2021-11-24 | Z-0250-2022 | Class II | REGARD Basic Cataract tray | ROi CPS LLC |
| 2021-11-24 | Z-0251-2022 | Class II | REGARD Core Biopsy Tray | ROi CPS LLC |
| 2021-11-24 | Z-0252-2022 | Class II | REGARD Ear Tray | ROi CPS LLC |
| 2021-11-24 | Z-0253-2022 | Class II | REGARD Newborn Tray | ROi CPS LLC |
| 2021-11-24 | Z-0254-2022 | Class II | REGARD Stereotactic Tray | ROi CPS LLC |
| 2021-11-24 | Z-0255-2022 | Class II | REGARD Ultrasound Tray | ROi CPS LLC |
| 2021-11-24 | Z-0256-2022 | Class II | REGARD Vitrectomy Tray | ROi CPS LLC |
| 2021-11-24 | Z-0257-2022 | Class II | LEEP PRECISION Integrated System | CooperSurgical, Inc. |
| 2021-11-24 | Z-0258-2022 | Class II | LEEP PRECISION Integrated System | CooperSurgical, Inc. |
| 2021-11-24 | Z-0259-2022 | Class II | LEEP PRECISION Generator 120V Cooper Surgical Part Number: LP-20-120 | CooperSurgical, Inc. |
| 2021-11-24 | Z-0260-2022 | Class II | LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220 | CooperSurgical, Inc. |
| 2021-11-24 | Z-0261-2022 | Class II | Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number:… | CooperSurgical, Inc. |
| 2021-11-24 | Z-0262-2022 | Class II | Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number:… | CooperSurgical, Inc. |
| 2021-11-24 | Z-0263-2022 | Class II | Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number:… | CooperSurgical, Inc. |
| 2021-11-24 | Z-0264-2022 | Class II | Permobil TiLite | TiSport, Llc |