| Reported | Recall | Class | Product | Firm |
|---|
| 2022-02-16 | Z-0579-2022 | Class II | Baxter CAPD System Transfer Set | Baxter Healthcare Corporation |
| 2022-02-16 | Z-0580-2022 | Class II | Baxter CAPD System Transfer Set | Baxter Healthcare Corporation |
| 2022-02-16 | Z-0581-2022 | Class III | KWIK-STIK | Microbiologics Inc |
| 2022-02-16 | Z-0582-2022 | Class II | KWIK-STIK | Microbiologics Inc |
| 2022-02-16 | Z-0583-2022 | Class II | LYFO DISK | Microbiologics Inc |
| 2022-02-16 | Z-0584-2022 | Class II | QC Sets and Panels: KWIK-STIK" 2 Pack | Microbiologics Inc |
| 2022-02-16 | Z-0585-2022 | Class II | KWIK-STIK | Microbiologics Inc |
| 2022-02-16 | Z-0586-2022 | Class II | LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro… | Microbiologics Inc |
| 2022-02-16 | Z-0587-2022 | Class II | QC Sets and Panels | Microbiologics Inc |
| 2022-02-16 | Z-0588-2022 | Class II | QC Sets and Panels | Microbiologics Inc |
| 2022-02-16 | Z-0589-2022 | Class II | QC Sets and Panels | Microbiologics Inc |
| 2022-02-16 | Z-0590-2022 | Class II | GE Healthcare MR superconducting magnets | GE Healthcare, LLC |
| 2022-02-16 | Z-0591-2022 | Class II | GE Healthcare MR superconducting magnets | GE Healthcare, LLC |
| 2022-02-16 | Z-0592-2022 | Class II | GE Healthcare MR superconducting magnets | GE Healthcare, LLC |
| 2022-02-16 | Z-0593-2022 | Class II | GE Healthcare MR superconducting magnets | GE Healthcare, LLC |
| 2022-02-16 | Z-0594-2022 | Class II | GE Healthcare MR superconducting magnets | GE Healthcare, LLC |
| 2022-02-16 | Z-0595-2022 | Class II | GE Healthcare MR superconducting magnets | GE Healthcare, LLC |
| 2022-02-16 | Z-0596-2022 | Class II | GE Healthcare MR superconducting magnets | GE Healthcare, LLC |
| 2022-02-16 | Z-0597-2022 | Class II | GE Healthcare MR superconducting magnets | GE Healthcare, LLC |
| 2022-02-16 | Z-0598-2022 | Class II | GE Healthcare MR superconducting magnets | GE Healthcare, LLC |
| 2022-02-16 | Z-0599-2022 | Class II | GE Healthcare MR superconducting magnets | GE Healthcare, LLC |
| 2022-02-16 | Z-0600-2022 | Class II | GE Healthcare MR superconducting magnets | GE Healthcare, LLC |
| 2022-02-16 | Z-0601-2022 | Class II | GE Healthcare MR superconducting magnets | GE Healthcare, LLC |
| 2022-02-16 | Z-0602-2022 | Class II | GE Healthcare MR superconducting magnets | GE Healthcare, LLC |
| 2022-02-16 | Z-0603-2022 | Class II | GE Healthcare MR superconducting magnets | GE Healthcare, LLC |
| 2022-02-16 | Z-0604-2022 | Class II | GE Healthcare MR superconducting magnets | GE Healthcare, LLC |
| 2022-02-16 | Z-0605-2022 | Class II | GE Healthcare MR superconducting magnets | GE Healthcare, LLC |
| 2022-02-16 | Z-0606-2022 | Class II | GE Healthcare MR superconducting magnets | GE Healthcare, LLC |
| 2022-02-16 | Z-0607-2022 | Class II | GE Healthcare MR superconducting magnets | GE Healthcare, LLC |
| 2022-02-16 | Z-0608-2022 | Class II | GE Healthcare MR superconducting magnets | GE Healthcare, LLC |
| 2022-02-16 | Z-0609-2022 | Class II | GE Healthcare MR superconducting magnets | GE Healthcare, LLC |
| 2022-02-16 | Z-0610-2022 | Class II | GE Healthcare MR superconducting magnets | GE Healthcare, LLC |
| 2022-02-16 | Z-0611-2022 | Class II | GE Healthcare MR superconducting magnets | GE Healthcare, LLC |
| 2022-02-16 | Z-0612-2022 | Class II | GE Healthcare MR superconducting magnets | GE Healthcare, LLC |
| 2022-02-16 | Z-0613-2022 | Class II | GE Healthcare MR superconducting magnets | GE Healthcare, LLC |
| 2022-02-16 | Z-0614-2022 | Class II | GE Healthcare MR superconducting magnets | GE Healthcare, LLC |
| 2022-02-16 | Z-0615-2022 | Class II | GE Healthcare MR superconducting magnets | GE Healthcare, LLC |
| 2022-02-16 | Z-0616-2022 | Class II | GE Healthcare MR superconducting magnets | GE Healthcare, LLC |
| 2022-02-16 | Z-0617-2022 | Class II | GE Healthcare MR superconducting magnets | GE Healthcare, LLC |
| 2022-02-16 | Z-0618-2022 | Class II | GE Healthcare MR superconducting magnets | GE Healthcare, LLC |
| 2022-02-16 | Z-0619-2022 | Class II | GE Healthcare MR superconducting magnets | GE Healthcare, LLC |
| 2022-02-16 | Z-0620-2022 | Class II | GE Healthcare MR superconducting magnets | GE Healthcare, LLC |
| 2022-02-16 | Z-0621-2022 | Class II | GE Healthcare MR superconducting magnets | GE Healthcare, LLC |
| 2022-02-16 | Z-0630-2022 | Class II | BD Veritor Plus Analyzer | Becton Dickinson & Co. |
| 2022-02-16 | Z-0631-2022 | Class II | ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a… | DePuy Orthopaedics, Inc. |
| 2022-02-16 | Z-0632-2022 | Class II | ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a… | DePuy Orthopaedics, Inc. |
| 2022-02-16 | Z-0633-2022 | Class II | CURAD REUSABLE GEL HOT/COLD PACK | MEDLINE INDUSTRIES, LP - Northfield |
| 2022-02-16 | Z-0634-2022 | Class II | Universal Chuck-The Universal Chuck is an Instrument Handle provided… | Synthes (USA) Products LLC |
| 2022-02-16 | Z-0635-2022 | Class II | Acufex Access Advanced Positioning Kit | Smith & Nephew, Inc. |
| 2022-02-16 | Z-0636-2022 | Class III | KWIK-STIK | Microbiologics Inc |
| 2022-02-16 | Z-0637-2022 | Class III | LYSO Disk | Microbiologics Inc |
| 2022-02-09 | Z-0480-2022 | Class I | CovClear COVID-19 Rapid Antigen Test | Empowered Diagnostics LLC |
| 2022-02-09 | Z-0481-2022 | Class I | ImmunoPass | Empowered Diagnostics LLC |
| 2022-02-09 | Z-0529-2022 | Class I | Baxter Spectrum IQ Infusion Pumps | Baxter Healthcare Corporation |
| 2022-02-09 | Z-0530-2022 | Class I | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library | Baxter Healthcare Corporation |
| 2022-02-09 | Z-0532-2022 | Class II | Vagus Nerve Stimulation | LivaNova USA, Inc. |
| 2022-02-09 | Z-0533-2022 | Class II | X060-0270 | XTANT Medical |
| 2022-02-09 | Z-0534-2022 | Class II | The DIXI Medical Microdeep Depth Electrode | DIXI MEDICAL USA |
| 2022-02-09 | Z-0535-2022 | Class II | The DIXI Medical Microdeep Depth Electrode | DIXI MEDICAL USA |
| 2022-02-09 | Z-0536-2022 | Class II | The DIXI Medical Microdeep Depth Electrode | DIXI MEDICAL USA |
| 2022-02-09 | Z-0537-2022 | Class II | The DIXI Medical Microdeep Depth Electrode | DIXI MEDICAL USA |
| 2022-02-09 | Z-0538-2022 | Class II | The DIXI Medical Microdeep Depth Electrode | DIXI MEDICAL USA |
| 2022-02-09 | Z-0539-2022 | Class II | The DIXI Medical Microdeep Depth Electrode | DIXI MEDICAL USA |
| 2022-02-09 | Z-0540-2022 | Class II | The DIXI Medical Microdeep Depth Electrode | DIXI MEDICAL USA |
| 2022-02-09 | Z-0541-2022 | Class II | The DIXI Medical Microdeep Depth Electrode | DIXI MEDICAL USA |
| 2022-02-09 | Z-0542-2022 | Class II | The DIXI Medical Microdeep Depth Electrode | DIXI MEDICAL USA |
| 2022-02-09 | Z-0543-2022 | Class III | KWIK-STIK | Microbiologics Inc |
| 2022-02-09 | Z-0544-2022 | Class III | KWIK-STIK | Microbiologics Inc |
| 2022-02-09 | Z-0545-2022 | Class II | CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY | Immuno-Mycologics, Inc |
| 2022-02-09 | Z-0546-2022 | Class III | KWIK-STI | Microbiologics Inc |
| 2022-02-09 | Z-0547-2022 | Class II | ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B | Siemens Medical Solutions USA, Inc. |
| 2022-02-09 | Z-0548-2022 | Class II | INTEGRA SURFIX ALPHA Screwdriver Torx 10 | Smith & Nephew, Inc. |
| 2022-02-09 | Z-0549-2022 | Class II | eCareManager version 4 | Philips North America Llc |
| 2022-02-09 | Z-0550-2022 | Class I | OXY-1 System | Abiomed, Inc. |
| 2022-02-09 | Z-0551-2022 | Class II | Spiration Valve System | Olympus Corporation of the Americas |
| 2022-02-09 | Z-0552-2022 | Class II | Premier Rotaclone | MEDLINE INDUSTRIES, LP - Northfield |
| 2022-02-09 | Z-0553-2022 | Class II | ARIES HSV 1&2 Assay | Luminex Corporation |
| 2022-02-09 | Z-0554-2022 | Class II | HARDY DIAGNOSTICS CatScreen | MEDLINE INDUSTRIES, LP - Northfield |
| 2022-02-09 | Z-0555-2022 | Class II | YOUNG DH Dry Heat Indicators | Young Dental Mfg Co I LLC |
| 2022-02-09 | Z-0556-2022 | Class II | The EnPlace is a single use trans-vaginal pelvic floor repair system… | FEMSelect Ltd |
| 2022-02-09 | Z-0557-2022 | Class II | Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm | Covidien Llc |
| 2022-02-09 | Z-0558-2022 | Class II | Celltrion DiaTrust COVID-19 Ag Rapid Test | CELLTRION USA INC |
| 2022-02-02 | Z-0493-2022 | Class I | Trilogy Evo | Philips Respironics, Inc. |
| 2022-02-02 | Z-0494-2022 | Class I | Trilogy Evo Repair Kit | Philips Respironics, Inc. |
| 2022-02-02 | Z-0515-2022 | Class II | Artis pheno with software VE20C- diagnostic imaging angiography… | Siemens Medical Solutions USA, Inc |
| 2022-02-02 | Z-0516-2022 | Class II | Artis icono biplane with software VE20C-diagnostic imaging… | Siemens Medical Solutions USA, Inc |
| 2022-02-02 | Z-0517-2022 | Class II | Artis icono floor with software VE20C-diagnostic imaging angiography… | Siemens Medical Solutions USA, Inc |
| 2022-02-02 | Z-0518-2022 | Class II | GE Vscan Extend | GE Healthcare, LLC |
| 2022-02-02 | Z-0519-2022 | Class II | GE Vscan Extend | GE Healthcare, LLC |
| 2022-02-02 | Z-0520-2022 | Class II | GE Vscan Extend | GE Healthcare, LLC |
| 2022-02-02 | Z-0521-2022 | Class II | GE Vscan Extend | GE Healthcare, LLC |
| 2022-02-02 | Z-0522-2022 | Class II | GE Vscan Extend | GE Healthcare, LLC |
| 2022-02-02 | Z-0523-2022 | Class II | GE Vscan Extend | GE Healthcare, LLC |
| 2022-02-02 | Z-0524-2022 | Class II | GE Vscan Extend | GE Healthcare, LLC |
| 2022-02-02 | Z-0525-2022 | Class II | API ID 32 C Strips | Biomerieux Inc |
| 2022-02-02 | Z-0526-2022 | Class II | 1 | NRT X-RAY A/S |
| 2022-02-02 | Z-0527-2022 | Class II | PIVO Blood Collection Device 20G | Velano Vascular |
| 2022-02-02 | Z-0528-2022 | Class II | MAGEC 1 System | NuVasive Specialized Orthopedics, Inc. |
| 2022-02-02 | Z-0531-2022 | Class II | 8mm FlexDex Needle Driver | FlexDex Inc. |
| 2022-01-26 | Z-0450-2022 | Class I | Medtronic HawkOne Directional Atherectomy System | ev3 Inc. |
| 2022-01-26 | Z-0451-2022 | Class I | Medtronic HawkOne Directional Atherectomy System | ev3 Inc. |
| 2022-01-26 | Z-0497-2022 | Class II | Senior Living Arial Emergency and Nurse Call Systems | Stanley Security Solutions Inc |
| 2022-01-26 | Z-0498-2022 | Class II | ARIES HSV 1&2 Assay | Luminex Corporation |
| 2022-01-26 | Z-0499-2022 | Class II | 1 | Siemens Medical Solutions USA, Inc |
| 2022-01-26 | Z-0500-2022 | Class II | ImagePilot Versions 1 | Konica Minolta Healthcare Americas, Inc. |
| 2022-01-26 | Z-0501-2022 | Class II | Draeger Fabius MRI Anesthesia Machine | Draeger Medical, Inc. |
| 2022-01-26 | Z-0502-2022 | Class II | greiner bio-one VACUETTE TUBE | Greiner Bio-One North America, Inc. |
| 2022-01-26 | Z-0503-2022 | Class II | VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack | Ortho-Clinical Diagnostics, Inc. |
| 2022-01-26 | Z-0504-2022 | Class II | Gentueri Viral Transport Medium | Gentueri Inc |
| 2022-01-26 | Z-0505-2022 | Class II | Infa-Therm Transport Mattress | Philips North America Llc |
| 2022-01-26 | Z-0506-2022 | Class II | Infant Heel Warmers w/strap | Philips North America Llc |
| 2022-01-26 | Z-0507-2022 | Class II | Heel Snuggler | Philips North America Llc |
| 2022-01-26 | Z-0508-2022 | Class II | Cardinal Infant Heel Warmer | Philips North America Llc |
| 2022-01-26 | Z-0509-2022 | Class II | Medichoice Infant Heel Warmer | Philips North America Llc |
| 2022-01-26 | Z-0510-2022 | Class II | Voyager Rollator-intended as a mechanical walker Model Number:… | Compass Health Brands (Corporate Office) |
| 2022-01-26 | Z-0511-2022 | Class II | KWIK-STIK 2 Pack | Microbiologics Inc |
| 2022-01-26 | Z-0512-2022 | Class II | Neodent Easypack Helix GM Acqua 3 | Straumann USA LLC |
| 2022-01-26 | Z-0513-2022 | Class II | Neodent Easypack Helix GM Acqua 3 | Straumann USA LLC |
| 2022-01-26 | Z-0514-2022 | Class II | SonarMed AirWave Monitor Kit | Covidien, LP |
| 2022-01-19 | Z-0465-2022 | Class II | Disposable Subdermal Needle Electrode | Technomed Europe |
| 2022-01-19 | Z-0466-2022 | Class II | Proteus 235 | Ion Beam Applications S.A. |
| 2022-01-19 | Z-0467-2022 | Class III | Ki Mobility | Ki Mobility Llc |
| 2022-01-19 | Z-0468-2022 | Class I | Vaporizer Sevoflurane Maquet Filling | Getinge Usa Sales Inc |
| 2022-01-19 | Z-0469-2022 | Class II | Regard | ROi CPS LLC |
| 2022-01-19 | Z-0470-2022 | Class II | RefleXion Medical Radiotherapy System | Reflexion Medical, Inc. |
| 2022-01-19 | Z-0471-2022 | Class II | Philips Azurion Interventional Fluoroscopic X-ray System with Azurion… | Philips North America Llc |
| 2022-01-19 | Z-0472-2022 | Class II | SOMATOM Confidence -Computed tomography systems Model 10590100 | Siemens Medical Solutions USA, Inc |
| 2022-01-19 | Z-0473-2022 | Class II | SOMATOM Definition AS-Computed tomography system Model 8098027 | Siemens Medical Solutions USA, Inc |
| 2022-01-19 | Z-0474-2022 | Class II | SOMATOM Edge Plus-Computed tomography system Model 1026700 | Siemens Medical Solutions USA, Inc |
| 2022-01-19 | Z-0475-2022 | Class II | SOMATOM Definition Edge -Computed tomography system Model 10590000 | Siemens Medical Solutions USA, Inc |
| 2022-01-19 | Z-0476-2022 | Class II | Wireless Footswtich used with the following Philips Allura Xper and… | Philips North America Llc |
| 2022-01-19 | Z-0477-2022 | Class II | OCT-Camera 211 01 A1 | Haag-Streit USA Inc |
| 2022-01-19 | Z-0478-2022 | Class II | OCT-Camera 211 01 A3 | Haag-Streit USA Inc |
| 2022-01-19 | Z-0479-2022 | Class II | Software BeamAdjust version 2 | PTW NORTH AMERICA CORPORATION |
| 2022-01-19 | Z-0482-2022 | Class II | Instavac Portable Suction Pump | Ohio Medical Corporation |
| 2022-01-19 | Z-0483-2022 | Class II | GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610 | DePuy Orthopaedics, Inc. |
| 2022-01-19 | Z-0484-2022 | Class II | GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100 | DePuy Orthopaedics, Inc. |
| 2022-01-19 | Z-0485-2022 | Class II | GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600 | DePuy Orthopaedics, Inc. |
| 2022-01-19 | Z-0486-2022 | Class II | GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100 | DePuy Orthopaedics, Inc. |
| 2022-01-19 | Z-0487-2022 | Class II | GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600 | DePuy Orthopaedics, Inc. |
| 2022-01-19 | Z-0488-2022 | Class II | GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100 | DePuy Orthopaedics, Inc. |
| 2022-01-19 | Z-0489-2022 | Class II | GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100 | DePuy Orthopaedics, Inc. |
| 2022-01-19 | Z-0490-2022 | Class II | GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100 | DePuy Orthopaedics, Inc. |
| 2022-01-19 | Z-0491-2022 | Class II | Medtronic Custom Perfusion kits | Medtronic Perfusion Systems |
| 2022-01-19 | Z-0492-2022 | Class II | Flat Panel Detector | Canon Medical System, USA, INC. |
| 2022-01-19 | Z-0495-2022 | Class II | LigaSure Blunt Tip Laparoscopic Sealer/Divider | Covidien Llc |
| 2022-01-19 | Z-0496-2022 | Class II | Electri-Cool II Portable Cold Therapy Unit | Gentherm Medical, LLC |
| 2022-01-12 | Z-0445-2022 | Class II | Invacare TDX SP2 with LiNX Gyro Power Wheelchair | Invacare Corporation |
| 2022-01-12 | Z-0446-2022 | Class II | Invacare AVIVA FX with LiNX Gyro Power Wheelchair | Invacare Corporation |
| 2022-01-12 | Z-0447-2022 | Class II | Invacare AVIVA Storm RX with LiNX Gyro Power Wheelchair | Invacare Corporation |
| 2022-01-12 | Z-0448-2022 | Class II | Flex-Thread Inserter Shaft intended for Fibula… | Flower Orthopedics Corporation |
| 2022-01-12 | Z-0449-2022 | Class II | Atellica CH 930 Analyzer with Software version: V1 | Siemens Healthcare Diagnostics, Inc. |
| 2022-01-12 | Z-0452-2022 | Class II | Biomeme SARS-CoV-2- Real Time RT-PCR Test | Biomeme, Inc. |
| 2022-01-12 | Z-0453-2022 | Class II | DYNANAIL MINI | Medshape, INC. |
| 2022-01-12 | Z-0454-2022 | Class III | iontoPATCH On-the-Go Patch Therapy | Tapemark Company |
| 2022-01-12 | Z-0455-2022 | Class II | QIAstat-Dx Respiratory SARS-CoV-2 Panel | Qiagen Sciences LLC |
| 2022-01-12 | Z-0456-2022 | Class II | DBB-06 Hemodialysis Delivery System | Nikkiso Ltd - Shizuoka Plant |
| 2022-01-12 | Z-0457-2022 | Class II | Simplexa Direct Amplification Disc Kit | DiaSorin Molecular LLC |
| 2022-01-12 | Z-0458-2022 | Class II | UROMEDICA Implantation Instrument Set | Uromedica Inc. |
| 2022-01-12 | Z-0459-2022 | Class II | Triathlon Pro Tibial Preparation Tray | Howmedica Osteonics Corp. |
| 2022-01-12 | Z-0460-2022 | Class II | Alinity m System | Abbott Molecular, Inc. |
| 2022-01-12 | Z-0461-2022 | Class II | Alinity m System | Abbott Molecular, Inc. |
| 2022-01-12 | Z-0462-2022 | Class II | Alinity m System | Abbott Molecular, Inc. |
| 2022-01-12 | Z-0463-2022 | Class II | Alinity m System | Abbott Molecular, Inc. |
| 2022-01-12 | Z-0464-2022 | Class II | Instructions for Use for all model numbers of the Medtronic Abre… | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2022-01-05 | Z-0418-2022 | Class II | Model B35200 | Medtronic Neuromodulation |
| 2022-01-05 | Z-0419-2022 | Class II | da Vinci SP Surgical systems with the following Model Name/ Model… | Intuitive Surgical, Inc. |
| 2022-01-05 | Z-0420-2022 | Class II | Ultimum HEMOSTASIS INTRODUCER 5f 1 | Abbott |
| 2022-01-05 | Z-0421-2022 | Class II | FLOWFLEX SARS-COV-2 Antigen Rapid Test | Migo Trading LLC |
| 2022-01-05 | Z-0422-2022 | Class II | RAPID 20 E | Biomerieux Inc |
| 2022-01-05 | Z-0423-2022 | Class II | Affected components are limited to the Monoprice charging cable | Forbes Rehab Services Inc |
| 2022-01-05 | Z-0424-2022 | Class II | VIDAS PRG Progesterone | bioMerieux, Inc. |
| 2022-01-05 | Z-0425-2022 | Class II | VIDAS Clostridium Difficile Toxin A&B | bioMerieux, Inc. |
| 2022-01-05 | Z-0426-2022 | Class II | VIDAS Clostridium Difficile GDH | bioMerieux, Inc. |
| 2022-01-05 | Z-0427-2022 | Class II | VIDAS DEX@ | bioMerieux, Inc. |
| 2022-01-05 | Z-0428-2022 | Class II | VIDAS B | bioMerieux, Inc. |
| 2022-01-05 | Z-0429-2022 | Class II | VIDAS Mumps IgG | bioMerieux, Inc. |
| 2022-01-05 | Z-0430-2022 | Class II | VIDAS Measles IgG | bioMerieux, Inc. |
| 2022-01-05 | Z-0431-2022 | Class II | VIDAS TOXO IgG Avidity | bioMerieux, Inc. |
| 2022-01-05 | Z-0432-2022 | Class II | VIDAS RUB IgG | bioMerieux, Inc. |
| 2022-01-05 | Z-0433-2022 | Class II | VIDAS LH | bioMerieux, Inc. |
| 2022-01-05 | Z-0434-2022 | Class II | VIDAS FSH | bioMerieux, Inc. |
| 2022-01-05 | Z-0435-2022 | Class II | VIDAS Estradiol II | bioMerieux, Inc. |
| 2022-01-05 | Z-0436-2022 | Class II | VIDAS Lyme IgM II | bioMerieux, Inc. |
| 2022-01-05 | Z-0437-2022 | Class II | VIDAS Lyme IgG II | bioMerieux, Inc. |
| 2022-01-05 | Z-0438-2022 | Class II | VIDAS SARS-COV-2 IgM | bioMerieux, Inc. |
| 2022-01-05 | Z-0439-2022 | Class II | VIDAS SARS-COV-2 IgG | bioMerieux, Inc. |
| 2022-01-05 | Z-0440-2022 | Class II | Atellica CH ¿2-Microglobulin | Siemens Healthcare Diagnostics, Inc. |
| 2022-01-05 | Z-0441-2022 | Class II | ARTISTE with syngo RT Therapist-linear accelerator systems to deliver… | Siemens Medical Solutions USA, Inc |
| 2022-01-05 | Z-0442-2022 | Class II | Karl Storz Udel Sterilization Tray Instructions for Use | Karl Storz Endoscopy |
| 2022-01-05 | Z-0443-2022 | Class II | iDesign | AMO Manufacturing USA, LLC |
| 2022-01-05 | Z-0444-2022 | Class II | Catalys Precision Laser System | AMO Manufacturing USA, LLC |