| Reported | Recall | Class | Product | Firm |
|---|
| 2020-09-23 | Z-2957-2020 | Class III | Maquet/Getinge Rotaflow System Console US | Maquet Cardiovascular Us Sales, Llc |
| 2020-09-23 | Z-2958-2020 | Class II | WallFlexTM Biliary RX Fully Covered Stent System RMV | Boston Scientific Corporation |
| 2020-09-23 | Z-2959-2020 | Class II | Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32 | Terumo Cardiovascular Systems Corporation |
| 2020-09-23 | Z-2960-2020 | Class II | Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS… | Terumo Cardiovascular Systems Corporation |
| 2020-09-23 | Z-2961-2020 | Class II | Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32 | Terumo Cardiovascular Systems Corporation |
| 2020-09-23 | Z-2962-2020 | Class II | Lactate Dehydrogenase L-P | Randox Laboratories Ltd. |
| 2020-09-23 | Z-2963-2020 | Class II | Lactate Dehydrognease P-L | Randox Laboratories Ltd. |
| 2020-09-23 | Z-2964-2020 | Class II | Zenith Alpha Abdominal Endovascular Graft | Cook Inc. |
| 2020-09-23 | Z-2965-2020 | Class II | AM1015 Randox Ammonia | RANDOX LABORATORIES, LTD. |
| 2020-09-23 | Z-2966-2020 | Class II | AM1054 Randox Ammonia | RANDOX LABORATORIES, LTD. |
| 2020-09-23 | Z-2967-2020 | Class II | Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for… | Tosoh Bioscience Inc |
| 2020-09-23 | Z-2968-2020 | Class II | Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In… | Tosoh Bioscience Inc |
| 2020-09-23 | Z-2969-2020 | Class II | AVANOS MIC-KEY SF Gastrostomy Feeding Tube | Avanos Medical, Inc. |
| 2020-09-23 | Z-2970-2020 | Class II | Siemens epoc BGEM Test Card-In vitro diagnostic device for the… | Siemens Healthcare Diagnostics Inc |
| 2020-09-23 | Z-2971-2020 | Class II | Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference… | Cook Inc. |
| 2020-09-23 | Z-2972-2020 | Class II | Imactis Patient Fiducial | Imactis |
| 2020-09-23 | Z-2973-2020 | Class II | FlexLab | Inpeco S.A. |
| 2020-09-23 | Z-2974-2020 | Class II | Accelerator a3600 system with Sysmex XN-9000/XN-9100 Interface Module | Inpeco S.A. |
| 2020-09-23 | Z-2975-2020 | Class II | Aptio Automation systems with Sysmex XN-9000/XN-9100 Interface Module | Inpeco S.A. |
| 2020-09-23 | Z-2976-2020 | Class III | Model No:T-SPOT | Oxford Immunotec |
| 2020-09-23 | Z-2977-2020 | Class III | Model No:T-SPOT | Oxford Immunotec |
| 2020-09-23 | Z-2978-2020 | Class II | The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19… | Life Technologies Corporation |
| 2020-09-23 | Z-2979-2020 | Class II | The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19… | Life Technologies Corporation |
| 2020-09-23 | Z-2980-2020 | Class II | The Guardian Connect App CSS7200 iOS | Medtronic Inc. |
| 2020-09-23 | Z-2981-2020 | Class II | Elecsys Anti-TPO Assay on cobas e analyzers 411 | Roche Diagnostics Operations, Inc. |
| 2020-09-16 | Z-2882-2020 | Class I | BD Alaris System | CareFusion 303, Inc. |
| 2020-09-16 | Z-2909-2020 | Class I | Alaris System PC Unit Model 8015 | CareFusion 303, Inc. |
| 2020-09-16 | Z-2910-2020 | Class I | PC Unit Front Case with Keypad Replacement Kits: TC10008389 ASSY CASE… | CareFusion 303, Inc. |
| 2020-09-16 | Z-2937-2020 | Class II | SINGLES Carbide US-No | Hager & Meisinger Gmbh |
| 2020-09-16 | Z-2938-2020 | Class II | QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 | Qiagen Sciences LLC |
| 2020-09-16 | Z-2939-2020 | Class I | BD Alaris System PC Unit Model 8100 | CareFusion 303, Inc. |
| 2020-09-16 | Z-2940-2020 | Class II | Medcomp 15 | Medical Components, Inc dba MedComp |
| 2020-09-16 | Z-2943-2020 | Class II | Talladium Luminesse Zirconia Discs | Talladium Inc |
| 2020-09-16 | Z-2944-2020 | Class II | Merge PACS | Merge Healthcare, Inc. |
| 2020-09-16 | Z-2945-2020 | Class II | EVOS Screws | Smith & Nephew, Inc. |
| 2020-09-16 | Z-2946-2020 | Class II | Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is… | Smiths Medical ASD Inc. |
| 2020-09-16 | Z-2948-2020 | Class II | PROFEMUR Titanium and Cobalt Chrome modular necks | MicroPort Orthopedics Inc. |
| 2020-09-16 | Z-2949-2020 | Class II | Ion Catheter Reprocessing Cover | Intuitive Surgical, Inc. |
| 2020-09-16 | Z-2950-2020 | Class II | ION Reprocessing Accessories Kit | Intuitive Surgical, Inc. |
| 2020-09-16 | Z-2951-2020 | Class II | SICAT IMPLANT V2 | SICAT GMBH & CO. KG |
| 2020-09-09 | Z-2872-2020 | Class II | The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film… | Ge Healthcare |
| 2020-09-09 | Z-2911-2020 | Class II | Plastic Cannula HOLDEX Item # 450216 | C.A. Greiner & Sohne Gesellschaftmbh |
| 2020-09-09 | Z-2912-2020 | Class II | PROTEXIS Latex Micro Surgical Gloves Size 5 | Cardinal Health 200, LLC |
| 2020-09-09 | Z-2913-2020 | Class II | PROTEXIS Latex Micro Surgical Gloves Size 6 | Cardinal Health 200, LLC |
| 2020-09-09 | Z-2914-2020 | Class II | PROTEXIS Latex Micro Surgical Gloves Size 6 | Cardinal Health 200, LLC |
| 2020-09-09 | Z-2915-2020 | Class II | PROTEXIS Latex Micro Surgical Gloves Size 7 | Cardinal Health 200, LLC |
| 2020-09-09 | Z-2916-2020 | Class II | PROTEXIS Latex Micro Surgical Gloves Size 7 | Cardinal Health 200, LLC |
| 2020-09-09 | Z-2917-2020 | Class II | PROTEXIS Latex Micro Surgical Gloves Size 8 | Cardinal Health 200, LLC |
| 2020-09-09 | Z-2918-2020 | Class II | PROTEXIS Latex Micro Surgical Gloves Size 8 | Cardinal Health 200, LLC |
| 2020-09-09 | Z-2919-2020 | Class II | PROTEXIS Latex Micro Surgical Gloves Size 9 | Cardinal Health 200, LLC |
| 2020-09-09 | Z-2920-2020 | Class II | Thermo Scientific Remel Bordetella pertussis Agglutinating Serum… | Remel Europe Ltd. |
| 2020-09-09 | Z-2921-2020 | Class II | Siemens Sensis Vibe Hemo system in combination with the MicroPodTM… | Siemens Medical Solutions USA, Inc |
| 2020-09-09 | Z-2922-2020 | Class II | Pleur-evac Thoracic Catheters Catalog No: DTRC-20S The thoracic… | TELEFLEX MEDICAL INC |
| 2020-09-09 | Z-2923-2020 | Class II | Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent | RANDOX LABORATORIES, LTD. |
| 2020-09-09 | Z-2924-2020 | Class II | Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene… | RANDOX LABORATORIES, LTD. |
| 2020-09-09 | Z-2925-2020 | Class II | Cirq Arm System | Brainlab AG |
| 2020-09-09 | Z-2926-2020 | Class II | The Vantage Total Ankle Tibial Insert | Exactech, Inc. |
| 2020-09-09 | Z-2927-2020 | Class II | Dimension Vista High Sensitivity Troponin I | Siemens Healthcare Diagnostics, Inc. |
| 2020-09-09 | Z-2928-2020 | Class II | StimQ Peripheral Nerve Stimulator System | Stimwave Technologies Inc |
| 2020-09-09 | Z-2929-2020 | Class II | StimQ Peripheral Nerve Stimulator System | Stimwave Technologies Inc |
| 2020-09-09 | Z-2930-2020 | Class II | StimQ Peripheral Nerve Stimulator System | Stimwave Technologies Inc |
| 2020-09-09 | Z-2931-2020 | Class II | StimQ Peripheral Nerve Stimulator System | Stimwave Technologies Inc |
| 2020-09-09 | Z-2932-2020 | Class II | StimQ Peripheral Nerve Stimulator System | Stimwave Technologies Inc |
| 2020-09-09 | Z-2933-2020 | Class II | StimQ Peripheral Nerve Stimulator System | Stimwave Technologies Inc |
| 2020-09-09 | Z-2934-2020 | Class II | Symbia S-Series and Symbia T-Series | Siemens Medical Solutions USA, Inc. |
| 2020-09-09 | Z-2935-2020 | Class II | BD Alaris System | CareFusion 303, Inc. |
| 2020-09-09 | Z-2936-2020 | Class II | Parvovirus B19 IgG EIA kit Part No | Diasorin Inc. |
| 2020-09-02 | Z-2820-2020 | Class II | LDI Laser firmware lower than V02 | 89 NORTH |
| 2020-09-02 | Z-2831-2020 | Class II | Datascope Intra-Aortic Ballon Catheters | Datascope Corporation |
| 2020-09-02 | Z-2832-2020 | Class II | Datascope Intra-Aortic Balloon Catheters | Datascope Corporation |
| 2020-09-02 | Z-2833-2020 | Class II | Datascope Intra-Aortic Ballon Catheters | Datascope Corporation |
| 2020-09-02 | Z-2834-2020 | Class II | Datascope Intra-Aortic Ballon Catheters | Datascope Corporation |
| 2020-09-02 | Z-2835-2020 | Class II | Datascope Intra-Aortic Ballon Catheters | Datascope Corporation |
| 2020-09-02 | Z-2836-2020 | Class II | Datascope Intra-Aortic Ballon Catheters | Datascope Corporation |
| 2020-09-02 | Z-2837-2020 | Class II | Datascope Intra-Aortic Ballon Catheters | Datascope Corporation |
| 2020-09-02 | Z-2838-2020 | Class II | Datascope Intra-Aortic Ballon Catheters | Datascope Corporation |
| 2020-09-02 | Z-2839-2020 | Class II | Datascope Intra-Aortic Ballon Catheters | Datascope Corporation |
| 2020-09-02 | Z-2840-2020 | Class II | Datascope Intra-Aortic Ballon Catheters | Datascope Corporation |
| 2020-09-02 | Z-2841-2020 | Class II | Datascope Intra-Aortic Ballon Catheters | Datascope Corporation |
| 2020-09-02 | Z-2842-2020 | Class II | Datascope Intra-Aortic Ballon Catheters | Datascope Corporation |
| 2020-09-02 | Z-2843-2020 | Class II | Datascope Intra-Aortic Ballon Catheters | Datascope Corporation |
| 2020-09-02 | Z-2844-2020 | Class II | Datascope Intra-Aortic Ballon Catheters | Datascope Corporation |
| 2020-09-02 | Z-2845-2020 | Class II | Datascope Intra-Aortic Ballon Catheters | Datascope Corporation |
| 2020-09-02 | Z-2846-2020 | Class II | Datascope Intra-Aortic Ballon Catheters | Datascope Corporation |
| 2020-09-02 | Z-2847-2020 | Class II | Datascope Intra-Aortic Ballon Catheters | Datascope Corporation |
| 2020-09-02 | Z-2848-2020 | Class II | Cios Alpha | Siemens Medical Solutions USA, Inc |
| 2020-09-02 | Z-2849-2020 | Class II | Conformis iTotal Cruciate Retaining | Conformis, Inc. |
| 2020-09-02 | Z-2850-2020 | Class II | ALTERA Spacer ALTERA Spacer | Globus Medical, Inc. |
| 2020-09-02 | Z-2851-2020 | Class II | ALTERA Spacer ALTERA Spacer | Globus Medical, Inc. |
| 2020-09-02 | Z-2852-2020 | Class II | ALTERA Spacer ALTERA Spacer | Globus Medical, Inc. |
| 2020-09-02 | Z-2853-2020 | Class II | ALTERA Spacer ALTERA Spacer | Globus Medical, Inc. |
| 2020-09-02 | Z-2854-2020 | Class II | ALTERA Spacer ALTERA Spacer | Globus Medical, Inc. |
| 2020-09-02 | Z-2855-2020 | Class II | ALTERA Spacer ALTERA Spacer | Globus Medical, Inc. |
| 2020-09-02 | Z-2856-2020 | Class II | ALTERA Spacer ALTERA Spacer | Globus Medical, Inc. |
| 2020-09-02 | Z-2857-2020 | Class II | ALTERA Spacer ALTERA Spacer | Globus Medical, Inc. |
| 2020-09-02 | Z-2858-2020 | Class II | ALTERA Spacer ALTERA Spacer | Globus Medical, Inc. |
| 2020-09-02 | Z-2859-2020 | Class II | ALTERA Spacer ALTERA Spacer | Globus Medical, Inc. |
| 2020-09-02 | Z-2860-2020 | Class II | ALTERA Spacer ALTERA Spacer | Globus Medical, Inc. |
| 2020-09-02 | Z-2861-2020 | Class II | ALTERA Spacer ALTERA Spacer | Globus Medical, Inc. |
| 2020-09-02 | Z-2862-2020 | Class II | ALTERA Spacer ALTERA Spacer | Globus Medical, Inc. |
| 2020-09-02 | Z-2863-2020 | Class II | ALTERA Spacer ALTERA Spacer | Globus Medical, Inc. |
| 2020-09-02 | Z-2864-2020 | Class II | ALTERA Spacer ALTERA Spacer | Globus Medical, Inc. |
| 2020-09-02 | Z-2865-2020 | Class II | ALTERA Spacer ALTERA Spacer | Globus Medical, Inc. |
| 2020-09-02 | Z-2866-2020 | Class II | ALTERA Spacer ALTERA Spacer | Globus Medical, Inc. |
| 2020-09-02 | Z-2867-2020 | Class II | ALTERA Spacer ALTERA Spacer | Globus Medical, Inc. |
| 2020-09-02 | Z-2868-2020 | Class II | ALTERA Spacer ALTERA Spacer | Globus Medical, Inc. |
| 2020-09-02 | Z-2869-2020 | Class II | ALTERA Spacer ALTERA Spacer | Globus Medical, Inc. |
| 2020-09-02 | Z-2870-2020 | Class II | ALTERA Spacer ALTERA Spacer | Globus Medical, Inc. |
| 2020-09-02 | Z-2871-2020 | Class II | ALTERA Spacer ALTERA Spacer | Globus Medical, Inc. |
| 2020-09-02 | Z-2873-2020 | Class II | VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro… | Ortho-Clinical Diagnostics |
| 2020-09-02 | Z-2874-2020 | Class II | VITROS Chemistry Products BuBc Slides | Ortho-Clinical Diagnostics |
| 2020-09-02 | Z-2875-2020 | Class II | VITROS XT Chemistry Products TBIL-ALKP Slides | Ortho-Clinical Diagnostics |
| 2020-09-02 | Z-2876-2020 | Class III | Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA… | OraSure Technologies, Inc. |
| 2020-09-02 | Z-2877-2020 | Class III | Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA… | OraSure Technologies, Inc. |
| 2020-09-02 | Z-2878-2020 | Class II | VITROS XT3400 Chemistry System | Ortho Clinical Diagnostics |
| 2020-09-02 | Z-2879-2020 | Class II | VITROS XT7600 Integrated System | Ortho Clinical Diagnostics |
| 2020-09-02 | Z-2880-2020 | Class II | CARTO 3 System | Biosense Webster (israel), Ltd. |
| 2020-09-02 | Z-2881-2020 | Class II | Klarity Vacuum Bags | Klarity Medical Products LLC |
| 2020-09-02 | Z-2883-2020 | Class II | CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a… | GE Healthcare, LLC |
| 2020-09-02 | Z-2884-2020 | Class II | Neurosign V4 Intraoperative Nerve monitor family of devices | The Magstim Company Limited |
| 2020-09-02 | Z-2885-2020 | Class II | System Model: Ultimax-i | Canon Medical System, USA, INC. |
| 2020-09-02 | Z-2886-2020 | Class II | Match Point System The Match Point System is intended to by uses as a… | Materialise N.V. |
| 2020-09-02 | Z-2887-2020 | Class II | Cios Alpha | Siemens Medical Solutions USA, Inc |
| 2020-09-02 | Z-2888-2020 | Class II | Cios Spin | Siemens Medical Solutions USA, Inc |
| 2020-09-02 | Z-2889-2020 | Class II | BD SafetyGlideTM 3ml 25G x 1 3mL SafetyGlide syringes | Becton Dickinson & Company |
| 2020-09-02 | Z-2890-2020 | Class II | Flexible Intubation Fiberscope | Karl Storz Endoscopy |
| 2020-09-02 | Z-2891-2020 | Class II | Flexible Intubation Video Endoscope | Karl Storz Endoscopy |
| 2020-09-02 | Z-2892-2020 | Class II | Flexible Intubation Fiberscope | Karl Storz Endoscopy |
| 2020-09-02 | Z-2893-2020 | Class II | Flexible Intubation Fiberscope | Karl Storz Endoscopy |
| 2020-09-02 | Z-2894-2020 | Class II | Flexible DCI Intubation Fiberscope | Karl Storz Endoscopy |
| 2020-09-02 | Z-2895-2020 | Class II | Flexible DCI Intubation Fiberscope | Karl Storz Endoscopy |
| 2020-09-02 | Z-2896-2020 | Class II | Flexible Intubation Video Endoscope | Karl Storz Endoscopy |
| 2020-09-02 | Z-2897-2020 | Class II | Flexible Intubation Video Endoscope | Karl Storz Endoscopy |
| 2020-09-02 | Z-2898-2020 | Class II | E | Siemens Medical Solutions USA, Inc. |
| 2020-09-02 | Z-2899-2020 | Class II | RayCare | RAYSEARCH LABORATORIES AB |
| 2020-09-02 | Z-2900-2020 | Class II | Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube | Neurovision Medical Products Inc |
| 2020-09-02 | Z-2901-2020 | Class II | Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube | Neurovision Medical Products Inc |
| 2020-09-02 | Z-2902-2020 | Class II | Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube | Neurovision Medical Products Inc |
| 2020-09-02 | Z-2903-2020 | Class II | Cobra x5 1-CH EMG ET Tube | Neurovision Medical Products Inc |
| 2020-09-02 | Z-2904-2020 | Class II | Cobra x5 1-Ch EMG ET Tube | Neurovision Medical Products Inc |
| 2020-09-02 | Z-2905-2020 | Class II | Cobra x5 1-Ch EMG ET Tube | Neurovision Medical Products Inc |
| 2020-09-02 | Z-2906-2020 | Class II | Cobra x5 2-Ch EMG ET Tube | Neurovision Medical Products Inc |
| 2020-09-02 | Z-2907-2020 | Class II | Cobra x5 2-Ch EMG ET Tube | Neurovision Medical Products Inc |
| 2020-09-02 | Z-2908-2020 | Class II | Cobra x5 2-Ch EMG ET Tube | Neurovision Medical Products Inc |
| 2020-08-26 | Z-2805-2020 | Class II | PVA | Precision Valve & Automation,Inc |
| 2020-08-26 | Z-2806-2020 | Class II | ClosureFast Micro Introducer Sheath Set | Argon Medical Devices, Inc |
| 2020-08-26 | Z-2807-2020 | Class II | Chembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatographic… | Chembio Diagnostics, Inc |
| 2020-08-26 | Z-2808-2020 | Class II | Chembio DPP¿ Micro Reader for use with the DPP¿ COVID-19 IgM/IgG… | Chembio Diagnostics, Inc |
| 2020-08-26 | Z-2809-2020 | Class II | Chembio DPP¿ Micro Reader II for use with the DPP¿ COVID-19 IgM/IgG… | Chembio Diagnostics, Inc |
| 2020-08-26 | Z-2810-2020 | Class II | Phillips 3 | Philips North America, LLC |
| 2020-08-26 | Z-2811-2020 | Class II | Phillips Charging Station | Philips North America, LLC |
| 2020-08-26 | Z-2812-2020 | Class II | Phillips Module Charger | Philips North America, LLC |
| 2020-08-26 | Z-2813-2020 | Class II | Smart Stapes Protheses Piston 0 | Olympus Corporation of the Americas |
| 2020-08-26 | Z-2814-2020 | Class II | Smart Stapes Protheses Piston 0 | Olympus Corporation of the Americas |
| 2020-08-26 | Z-2815-2020 | Class II | PAPR | Whirlpool Corporation |
| 2020-08-26 | Z-2816-2020 | Class II | DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes… | Synthes (USA) Products LLC |
| 2020-08-26 | Z-2817-2020 | Class II | Golden Technologies Model Number PR515 Lift Chair | Golden Technologies, Inc. |
| 2020-08-26 | Z-2818-2020 | Class II | Single RIKKI Retractor | Smith & Nephew, Inc. |
| 2020-08-26 | Z-2819-2020 | Class II | Positron Emission Tomography and Computed Tomography System | Shanghai United Imaging Healthcare Co., Ltd. |
| 2020-08-26 | Z-2821-2020 | Class II | Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame… | ARJOHUNTLEIGH POLSKA Sp. z.o.o. |
| 2020-08-26 | Z-2822-2020 | Class II | Alaris Pump Module Model 8100 | CareFusion 303, Inc. |
| 2020-08-26 | Z-2823-2020 | Class II | Alaris Syringe Module Model 8110 | CareFusion 303, Inc. |
| 2020-08-26 | Z-2824-2020 | Class II | Alaris PCA Module Model 8120 | CareFusion 303, Inc. |
| 2020-08-26 | Z-2825-2020 | Class II | Alaris EtCO2 Module Model 8300 | CareFusion 303, Inc. |
| 2020-08-26 | Z-2826-2020 | Class II | Alaris SpO2 Module Model 8210 and Model 8220 | CareFusion 303, Inc. |
| 2020-08-26 | Z-2827-2020 | Class II | POLARSTEM COLLAR Reamer Guide | Smith & Nephew Orthopaedics AG |
| 2020-08-26 | Z-2828-2020 | Class II | NobelReplace Conical Connection | NOBEL BIOCARE SERVICES AG |
| 2020-08-26 | Z-2829-2020 | Class II | Cytocell LPH533-A NUP98 Distal Probe Green | Cytocell Ltd. |
| 2020-08-26 | Z-2830-2020 | Class II | Ultra/Phonic Focus BP Conforming Gel Pads | Pharmaceutical Innovations, Inc. |
| 2020-08-19 | Z-2770-2020 | Class II | VITROS Anti-SARS-CoV-2 Total Reagent | Ortho Clinical Diagnostics |
| 2020-08-19 | Z-2771-2020 | Class II | VITROS Anti-SARS-CoV-2 IgG Reagent Pack | Ortho Clinical Diagnostics |
| 2020-08-19 | Z-2772-2020 | Class II | OmniTom Computed tomography x-ray system | NeuroLogica Corporation |
| 2020-08-19 | Z-2773-2020 | Class II | Proteus 235 The Proton Therapy System | Ion Beam Applications S.A. |
| 2020-08-19 | Z-2774-2020 | Class II | Tibial knee prosthesis | Smith & Nephew, Inc. |
| 2020-08-19 | Z-2775-2020 | Class II | Verigene Processor SP with assay: Luminex | Luminex Corporation |
| 2020-08-19 | Z-2776-2020 | Class II | Verigene Processor SP with assay Luminex | Luminex Corporation |
| 2020-08-19 | Z-2777-2020 | Class II | PERI-LOC TARGETER 4 | Smith & Nephew, Inc. |
| 2020-08-19 | Z-2778-2020 | Class II | Anjon Bremer Molded Crown | Anjon Holdings |
| 2020-08-19 | Z-2779-2020 | Class II | STAT KIT Z-1000 emergency medical kit HealthFirst | HF Acquisition Co. LLC |
| 2020-08-19 | Z-2780-2020 | Class II | Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal /… | Maquet Cardiovascular Us Sales, Llc |
| 2020-08-19 | Z-2781-2020 | Class III | AVE 2 Birthing Bed | Linet Americas |
| 2020-08-19 | Z-2782-2020 | Class II | Calcaneus Plate | Flower Orthopedics Corporation |
| 2020-08-19 | Z-2783-2020 | Class II | Calcaneus Plate | Flower Orthopedics Corporation |
| 2020-08-19 | Z-2784-2020 | Class II | Calcaneus Plate | Flower Orthopedics Corporation |
| 2020-08-19 | Z-2785-2020 | Class II | Calcaneus Plate | Flower Orthopedics Corporation |
| 2020-08-19 | Z-2786-2020 | Class II | Calcaneus Plate | Flower Orthopedics Corporation |
| 2020-08-19 | Z-2787-2020 | Class II | Calcaneus Plate | Flower Orthopedics Corporation |
| 2020-08-19 | Z-2788-2020 | Class II | HealthFirst Emergency Medical Kit | HF Acquisition Co., LLC |
| 2020-08-19 | Z-2789-2020 | Class II | STAT KIT | HF Acquisition Co., LLC |
| 2020-08-19 | Z-2790-2020 | Class II | STAT KIT Model 550 Emergency Medical Kit P/N: 1009580 containing… | HF Acquisition Co., LLC |
| 2020-08-19 | Z-2791-2020 | Class II | STAT KIT Model 550AI Emergency Medical Kit | HF Acquisition Co., LLC |
| 2020-08-19 | Z-2792-2020 | Class II | BRAINLAB Curve | Brainlab AG |
| 2020-08-19 | Z-2793-2020 | Class II | BRAINLAB Kick 2 | Brainlab AG |
| 2020-08-19 | Z-2794-2020 | Class II | Philips HeartStart MRx | Philips North America, LLC |
| 2020-08-19 | Z-2795-2020 | Class II | Bioseal Trachea Extender 1/pl 50pk/Cs | Bioseal Corporation |
| 2020-08-19 | Z-2796-2020 | Class II | Hardware removal kit | Wright Medical Technology, Inc. |
| 2020-08-19 | Z-2797-2020 | Class II | Screw Removal Case Assembly | Wright Medical Technology, Inc. |
| 2020-08-19 | Z-2798-2020 | Class II | Barricaid Annual Closure Device | Intrinsic Therapeutics, Inc. |
| 2020-08-19 | Z-2799-2020 | Class II | uEXPLORER PET/CT Diagnostic Imaging System | Shanghai United Imaging Healthcare Co., Ltd. |
| 2020-08-19 | Z-2800-2020 | Class II | uMI 550 PET/CT Diagnostic Imaging System | Shanghai United Imaging Healthcare Co., Ltd. |