| Reported | Recall | Class | Product | Firm |
|---|
| 2021-02-17 | Z-1034-2021 | Class II | NEEDLEMASTER 5MMx 21G UPPER | Aomori Olympus Co., Ltd. |
| 2021-02-17 | Z-1035-2021 | Class II | NEEDLEMASTER 3MMx 23G LOWER | Aomori Olympus Co., Ltd. |
| 2021-02-17 | Z-1036-2021 | Class II | NEEDLEMASTER 5MMx 25G UPPER | Aomori Olympus Co., Ltd. |
| 2021-02-17 | Z-1037-2021 | Class II | NEEDLEMASTER 6MMx 21G UPPER | Aomori Olympus Co., Ltd. |
| 2021-02-17 | Z-1038-2021 | Class II | NEEDLEMASTER 6MMx 23G UPPER | Aomori Olympus Co., Ltd. |
| 2021-02-17 | Z-1039-2021 | Class II | NEEDLEMASTER 6MMx 25G UPPER | Aomori Olympus Co., Ltd. |
| 2021-02-17 | Z-1040-2021 | Class II | NEEDLEMASTER 3MMx 23G LOWER | Aomori Olympus Co., Ltd. |
| 2021-02-17 | Z-1041-2021 | Class II | NEEDLEMASTER 3MMx 26G LOWER | Aomori Olympus Co., Ltd. |
| 2021-02-17 | Z-1042-2021 | Class II | NEEDLEMASTER 4MMx 23G LOWER | Aomori Olympus Co., Ltd. |
| 2021-02-17 | Z-1043-2021 | Class II | NEEDLEMASTER 4MMx 25G LOWER | Aomori Olympus Co., Ltd. |
| 2021-02-17 | Z-1044-2021 | Class II | NEEDLEMASTER 4MMx 26G LOWER | Aomori Olympus Co., Ltd. |
| 2021-02-17 | Z-1045-2021 | Class II | NEEDLEMASTER 3MMx 23G LOWER | Aomori Olympus Co., Ltd. |
| 2021-02-17 | Z-1046-2021 | Class II | NEEDLEMASTER 5MMx 25G LOWER | Aomori Olympus Co., Ltd. |
| 2021-02-17 | Z-1047-2021 | Class II | NEEDLEMASTER 6MMx 23G LOWER | Aomori Olympus Co., Ltd. |
| 2021-02-17 | Z-1048-2021 | Class II | NEEDLEMASTER 6MMx 25G LOWER | Aomori Olympus Co., Ltd. |
| 2021-02-17 | Z-1049-2021 | Class II | NEEDLEMASTER 1 | Aomori Olympus Co., Ltd. |
| 2021-02-17 | Z-1050-2021 | Class II | K-201 GUIDE SHEATH KIT 2 | Aomori Olympus Co., Ltd. |
| 2021-02-17 | Z-1051-2021 | Class II | K-202 GUIDE SHEATH KIT 2 | Aomori Olympus Co., Ltd. |
| 2021-02-17 | Z-1052-2021 | Class II | K-203 GUIDE SHEATH KIT 2 | Aomori Olympus Co., Ltd. |
| 2021-02-17 | Z-1053-2021 | Class II | K-204 GUIDE SHEATH KIT 2 | Aomori Olympus Co., Ltd. |
| 2021-02-17 | Z-1054-2021 | Class II | NA-401D-1321 ASPIRATION NEEDLE | Aomori Olympus Co., Ltd. |
| 2021-02-17 | Z-1055-2021 | Class II | NA-401D-1521 ASPIRATION NEEDLE | Aomori Olympus Co., Ltd. |
| 2021-02-17 | Z-1056-2021 | Class II | NA-411D-1321 ASPIRATION NEEDLE | Aomori Olympus Co., Ltd. |
| 2021-02-17 | Z-1057-2021 | Class II | NA-411D-1521 ASPIRATION NEEDLE | Aomori Olympus Co., Ltd. |
| 2021-02-17 | Z-1058-2021 | Class II | NA-601D-1519 ASPIRATION NEEDLE | Aomori Olympus Co., Ltd. |
| 2021-02-17 | Z-1059-2021 | Class II | NA-201SX-4021 ASPIRATION NEEDLE VIZISHOT 21G | Aomori Olympus Co., Ltd. |
| 2021-02-17 | Z-1060-2021 | Class II | NA-201SX-4022-ASPIRATION NEEDLE VIZISHOT 22G | Aomori Olympus Co., Ltd. |
| 2021-02-17 | Z-1061-2021 | Class II | NA-201SX-4022-B ASPIRATION NEEDLE ViziShot 22G | Aomori Olympus Co., Ltd. |
| 2021-02-17 | Z-1062-2021 | Class II | NA-201SX-4022-C ASPIRATION NEEDLE ViziShot 22G w/o stylet | Aomori Olympus Co., Ltd. |
| 2021-02-17 | Z-1063-2021 | Class II | PBD-203-0703 BILIARY STENT | Aomori Olympus Co., Ltd. |
| 2021-02-17 | Z-1064-2021 | Class II | PBD-203-0704 BILIARY STENT | Aomori Olympus Co., Ltd. |
| 2021-02-17 | Z-1065-2021 | Class II | PBD-203-0707 BILIARY STENT | Aomori Olympus Co., Ltd. |
| 2021-02-17 | Z-1066-2021 | Class II | PBD-203-0710 BILIARY STENT | Aomori Olympus Co., Ltd. |
| 2021-02-17 | Z-1067-2021 | Class II | MAJ-244 SINGLE USE 30MM REPLACEMENT BASKET | Aomori Olympus Co., Ltd. |
| 2021-02-17 | Z-1068-2021 | Class II | MAJ-247 SINGLE USE 30MM REPLACEMENT BASKET | Aomori Olympus Co., Ltd. |
| 2021-02-17 | Z-1069-2021 | Class II | NA-200H-8022 22G EZSHOT ASPIRATION NEEDLE | Aomori Olympus Co., Ltd. |
| 2021-02-17 | Z-1070-2021 | Class II | CRESCENT SNARE | Aomori Olympus Co., Ltd. |
| 2021-02-17 | Z-1071-2021 | Class II | CRESCENT SNARE | Aomori Olympus Co., Ltd. |
| 2021-02-17 | Z-1072-2021 | Class II | Argon Medical Devices TLAB | Argon Medical Devices, Inc |
| 2021-02-17 | Z-1073-2021 | Class II | Argon Medical Devices TLAB | Argon Medical Devices, Inc |
| 2021-02-17 | Z-1074-2021 | Class II | Argon Medical Devices TLAB | Argon Medical Devices, Inc |
| 2021-02-17 | Z-1075-2021 | Class II | Argon Medical Devices TLAB | Argon Medical Devices, Inc |
| 2021-02-17 | Z-1076-2021 | Class II | Argon Medical Devices TLAB | Argon Medical Devices, Inc |
| 2021-02-17 | Z-1077-2021 | Class II | Argon Medical Devices TLAB | Argon Medical Devices, Inc |
| 2021-02-17 | Z-1078-2021 | Class II | Covidien ChemoPlus Chemo Spill Kit | Cardinal Health 200, LLC |
| 2021-02-17 | Z-1079-2021 | Class II | CHEMOBLOC Preparation and Administration Kit | Cardinal Health 200, LLC |
| 2021-02-17 | Z-1080-2021 | Class II | CHEMOPLUS DRUG SPILL KIT HOS | Cardinal Health 200, LLC |
| 2021-02-17 | Z-1081-2021 | Class II | ChemoPlus Drug Spill Kit-INSTI | Cardinal Health 200, LLC |
| 2021-02-17 | Z-1082-2021 | Class II | Kendall Spill Kit | Cardinal Health 200, LLC |
| 2021-02-17 | Z-1083-2021 | Class II | ChemoPlus" Chemo Prep & Admin Kit | Cardinal Health 200, LLC |
| 2021-02-17 | Z-1084-2021 | Class II | WAHL 4212 HEATED MASSAGER | Wahl Clipper Corp |
| 2021-02-17 | Z-1085-2021 | Class II | Gown Isolation W/Ties Univ Ylw | Cardinal Health 200, LLC |
| 2021-02-17 | Z-1086-2021 | Class II | Gown Isolation W/Ties Xl Ylw | Cardinal Health 200, LLC |
| 2021-02-17 | Z-1087-2021 | Class II | Gown Isolation W/Ties Univ Blu | Cardinal Health 200, LLC |
| 2021-02-17 | Z-1088-2021 | Class II | Gown Isolation W/Ties Xl Blue | Cardinal Health 200, LLC |
| 2021-02-17 | Z-1089-2021 | Class II | Lab Coats SMS Large Blue | Cardinal Health 200, LLC |
| 2021-02-17 | Z-1090-2021 | Class II | Lab Coats SMS X-Large Blue | Cardinal Health 200, LLC |
| 2021-02-17 | Z-1091-2021 | Class II | Lab Coats SMS 2X-Large Blue | Cardinal Health 200, LLC |
| 2021-02-17 | Z-1092-2021 | Class II | Lab Coats SMS Medium White | Cardinal Health 200, LLC |
| 2021-02-17 | Z-1093-2021 | Class II | Lab Coats SMS Large White | Cardinal Health 200, LLC |
| 2021-02-17 | Z-1094-2021 | Class II | Lab Coats SMS 2X-Large White | Cardinal Health 200, LLC |
| 2021-02-17 | Z-1095-2021 | Class II | Gown Kendall Blue RG | Cardinal Health 200, LLC |
| 2021-02-17 | Z-1096-2021 | Class II | Gown Kendall Blue L | Cardinal Health 200, LLC |
| 2021-02-17 | Z-1097-2021 | Class II | Gown Kendall Blue XXL | Cardinal Health 200, LLC |
| 2021-02-17 | Z-1098-2021 | Class II | 9180 Electrolyte Analyzer | Roche Diagnostics Operations, Inc. |
| 2021-02-17 | Z-1099-2021 | Class II | Aquarius LPH 511-A CRLF2 Distal Probe Green | Cytocell Ltd. |
| 2021-02-17 | Z-1100-2021 | Class II | Arjo Flat Dynamic Positioning System | Arjohuntleigh Magog, Inc. |
| 2021-02-17 | Z-1101-2021 | Class II | GE Healthcare Precision 600FP | GE Healthcare, LLC |
| 2021-02-17 | Z-1102-2021 | Class II | Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set | Baxter Healthcare Corporation |
| 2021-02-17 | Z-1103-2021 | Class II | Universal Femoral Sleeves | DePuy Orthopaedics, Inc. |
| 2021-02-17 | Z-1104-2021 | Class II | Infinity Acute Care System | Draegar Medical Systems, Inc. |
| 2021-02-17 | Z-1105-2021 | Class II | Bemer-Set/ Pro-Set for the following models: REF | BEMER INT. AG |
| 2021-02-17 | Z-1106-2021 | Class II | Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous… | Arrow International Inc |
| 2021-02-17 | Z-1107-2021 | Class II | EliA dsDNA Well | Phadia US Inc |
| 2021-02-17 | Z-1108-2021 | Class II | Cascade Abrazo aPTT Test Card | Helena Laboratories, Corp. |
| 2021-02-10 | Z-0925-2021 | Class I | Liko Multirall 200 overhead lift- overhead lift is a general-purpose… | Hill-Rom, Inc. |
| 2021-02-10 | Z-0933-2021 | Class II | VERSABOND AB 40 GRAMS FORMULATION 2 | Smith & Nephew, Inc. |
| 2021-02-10 | Z-0934-2021 | Class II | Neuroreader Medical Image Processing Software | Brainreader ApS |
| 2021-02-10 | Z-0938-2021 | Class II | ALung Technologies Hemolung Respiratory Assist System | Alung Technologies Inc |
| 2021-02-10 | Z-0939-2021 | Class II | FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes | Baxter Healthcare Corporation |
| 2021-02-10 | Z-0940-2021 | Class III | Nucleic acid-based in vitro diagnostic devices for the detection of… | Biomeme, Inc. |
| 2021-02-10 | Z-0941-2021 | Class II | SARS-CoV-2 Antigen Test | Qiagen Sciences LLC |
| 2021-02-10 | Z-0942-2021 | Class II | Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid… | Fresenius Medical Care Holdings, Inc. |
| 2021-02-10 | Z-0943-2021 | Class II | Optilite Freelite Mx Kappa Free Kit REF LK016 | The Binding Site Group, Ltd. |
| 2021-02-10 | Z-0944-2021 | Class II | Philips EPIQ Diagnostic Ultrasound System | Philips Ultrasound Inc |
| 2021-02-10 | Z-0945-2021 | Class II | Tourni-Cot | Mar-Med Co |
| 2021-02-10 | Z-0946-2021 | Class I | Medtronic HVAD Pump Implant Kits | Heartware, Inc. |
| 2021-02-10 | Z-0947-2021 | Class II | Philips EPIQ Diagnostic Ultrasound System | Philips Ultrasound Inc |
| 2021-02-10 | Z-0948-2021 | Class II | REFRESH CONTACTS¿ Contact Lens Comfort Drops 0 | Allergan PLC |
| 2021-02-10 | Z-0949-2021 | Class II | Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14… | Riverpoint Medical, LLC |
| 2021-02-10 | Z-0952-2021 | Class II | Harmony Referral System | Topcon Medical Systems, Inc. |
| 2021-02-10 | Z-0953-2021 | Class II | Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin… | Ethicon, Inc. |
| 2021-02-03 | Z-0612-2020 | Class II | REF 800-05-035 | Enztec Limited |
| 2021-02-03 | Z-0727-2021 | Class II | ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system | PHILIPS HOME HEALTHCARE SOLUTION |
| 2021-02-03 | Z-0865-2021 | Class II | PSG-1100 Sleep Diagnostic System | Nihon Kohden America Inc |
| 2021-02-03 | Z-0885-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1053613 | Respironics California, LLC |
| 2021-02-03 | Z-0886-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1053614 | Respironics California, LLC |
| 2021-02-03 | Z-0887-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1053615 | Respironics California, LLC |
| 2021-02-03 | Z-0888-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1053616 | Respironics California, LLC |
| 2021-02-03 | Z-0889-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1053617 | Respironics California, LLC |
| 2021-02-03 | Z-0890-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1053618 | Respironics California, LLC |
| 2021-02-03 | Z-0891-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1076709 | Respironics California, LLC |
| 2021-02-03 | Z-0892-2021 | Class II | Philips Respironics V60 Ventilator Part Number R1053618 | Respironics California, LLC |
| 2021-02-03 | Z-0893-2021 | Class II | Philips Respironics V60 Ventilator Part Number R1076709 | Respironics California, LLC |
| 2021-02-03 | Z-0894-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1076716 | Respironics California, LLC |
| 2021-02-03 | Z-0895-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1076717 | Respironics California, LLC |
| 2021-02-03 | Z-0896-2021 | Class II | Philips Respironics V60 Plus Ventilator Part Number 1137276 | Respironics California, LLC |
| 2021-02-03 | Z-0897-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1137292 | Respironics California, LLC |
| 2021-02-03 | Z-0898-2021 | Class II | Philips Respironics V60 Plus Ventilator Part Number 1138747 | Respironics California, LLC |
| 2021-02-03 | Z-0899-2021 | Class II | Philips Respironics V60 Ventilator Part Number DU1053617 | Respironics California, LLC |
| 2021-02-03 | Z-0900-2021 | Class II | Philips Respironics V60 Ventilator Part Number U1053617 | Respironics California, LLC |
| 2021-02-03 | Z-0901-2021 | Class II | Philips Respironics V680 Ventilator Part Number 850011 | Respironics California, LLC |
| 2021-02-03 | Z-0902-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1053613 | Respironics California, LLC |
| 2021-02-03 | Z-0903-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1053614 | Respironics California, LLC |
| 2021-02-03 | Z-0904-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1053615 | Respironics California, LLC |
| 2021-02-03 | Z-0905-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1053616 | Respironics California, LLC |
| 2021-02-03 | Z-0906-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1053617 | Respironics California, LLC |
| 2021-02-03 | Z-0907-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1053618 | Respironics California, LLC |
| 2021-02-03 | Z-0908-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1076709 | Respironics California, LLC |
| 2021-02-03 | Z-0909-2021 | Class II | Philips Respironics V60 Ventilator Part Number R1053618 | Respironics California, LLC |
| 2021-02-03 | Z-0910-2021 | Class II | Philips Respironics V60 Ventilator Part Number R1076709 | Respironics California, LLC |
| 2021-02-03 | Z-0911-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1076716 | Respironics California, LLC |
| 2021-02-03 | Z-0912-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1076717 | Respironics California, LLC |
| 2021-02-03 | Z-0913-2021 | Class II | Philips Respironics V60 Plus Ventilator Part Number 1137276 | Respironics California, LLC |
| 2021-02-03 | Z-0914-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1137292 | Respironics California, LLC |
| 2021-02-03 | Z-0915-2021 | Class II | Philips Respironics V60 Plus Ventilator Part Number 1138747 | Respironics California, LLC |
| 2021-02-03 | Z-0916-2021 | Class II | Philips Respironics V60 Ventilator Part Number DU1053617 | Respironics California, LLC |
| 2021-02-03 | Z-0917-2021 | Class II | Philips Respironics V680 Ventilator Part Number 850011 | Respironics California, LLC |
| 2021-02-03 | Z-0918-2021 | Class II | FUJIFILM Synapse PACS Software: versions 7 | Fujifilm Medical Systems U.S.A., Inc. |
| 2021-02-03 | Z-0919-2021 | Class II | Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no:… | Hardy Diagnostics |
| 2021-02-03 | Z-0920-2021 | Class II | SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner | OMNIlife science Inc. |
| 2021-02-03 | Z-0921-2021 | Class II | SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner | OMNIlife science Inc. |
| 2021-02-03 | Z-0922-2021 | Class II | SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner | OMNIlife science Inc. |
| 2021-02-03 | Z-0923-2021 | Class II | BD Stimex Insulated Needle 22G x 2 | Becton Dickinson & Company |
| 2021-02-03 | Z-0924-2021 | Class II | BD Regional Block Needles 22G x 1 | Becton Dickinson & Company |
| 2021-02-03 | Z-0926-2021 | Class II | Medtronic COBALT HF QUAD CRT-D MRI SureScan | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2021-02-03 | Z-0927-2021 | Class II | Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2021-02-03 | Z-0928-2021 | Class II | Medtronic Cobalt DR MRI SureScan DDPB3D1 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2021-02-03 | Z-0929-2021 | Class II | DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL | Neocis, Inc. |
| 2021-02-03 | Z-0930-2021 | Class II | B | Braxton Medical Corporation |
| 2021-02-03 | Z-0931-2021 | Class II | Yukon Polyaxial Screw Size 4 | K2M, Inc |
| 2021-02-03 | Z-0932-2021 | Class III | Wako HDL-C/LDL-C Calibrator | Fujifilm Medical Systems U.S.A., Inc. |
| 2021-02-03 | Z-0935-2021 | Class II | EMBLEM S-ICD pulse generators | Boston Scientific Corporation |
| 2021-02-03 | Z-0936-2021 | Class II | EMBLEM MRI S-ICD pulse generators | Boston Scientific Corporation |
| 2021-02-03 | Z-0937-2021 | Class II | therascreen PIK3CA RGQ PCR Kit | Qiagen Sciences LLC |
| 2021-02-03 | Z-1766-2020 | Class II | TRx4851A 2 | Philips North America, LLC |
| 2021-02-03 | Z-1767-2020 | Class II | TRx4841A 1 | Philips North America, LLC |
| 2021-02-03 | Z-2113-2020 | Class II | Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter | Stryker Sustainability Solutions |
| 2021-01-27 | Z-0848-2021 | Class I | Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 The Penumbra JET 7… | Penumbra Inc. |
| 2021-01-27 | Z-0849-2021 | Class I | Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration… | Penumbra Inc. |
| 2021-01-27 | Z-0850-2021 | Class I | Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration… | Penumbra Inc. |
| 2021-01-27 | Z-0851-2021 | Class I | Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX… | Penumbra Inc. |
| 2021-01-27 | Z-0866-2021 | Class II | OsteoVation | Skeletal Kinetics, Llc |
| 2021-01-27 | Z-0867-2021 | Class II | OsteoVation | Skeletal Kinetics, Llc |
| 2021-01-27 | Z-0868-2021 | Class II | Laerdal Compact Suction Unit | Laerdal Medical (Suzhou) Co., Ltd. |
| 2021-01-27 | Z-0869-2021 | Class II | Neurosign 100 | The Magstim Company Limited |
| 2021-01-27 | Z-0870-2021 | Class II | ACUITY Universal Cutter | Boston Scientific Corporation |
| 2021-01-27 | Z-0871-2021 | Class II | REF 27219-1 X1 | Medtronic Neurosurgery |
| 2021-01-27 | Z-0872-2021 | Class II | REF 27219-2 X1 | Medtronic Neurosurgery |
| 2021-01-27 | Z-0873-2021 | Class II | REF 27219-5 X1 | Medtronic Neurosurgery |
| 2021-01-27 | Z-0874-2021 | Class II | Portex Acapella DH Vibratory PEP Device | Smiths Medical ASD Inc. |
| 2021-01-27 | Z-0875-2021 | Class II | ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 | Beckman Coulter Inc. |
| 2021-01-27 | Z-0876-2021 | Class II | Reliance Vision Single-Chamber Washer/Disinfector | Steris Corporation |
| 2021-01-27 | Z-0877-2021 | Class II | uPath software 1 | Roche Molecular Systems, Inc. |
| 2021-01-27 | Z-0878-2021 | Class II | Synapse PACS Software Versions 5 | Fujifilm Medical Systems U.S.A., Inc. |
| 2021-01-27 | Z-0879-2021 | Class I | EMBLEM S-ICD Subcutaneous Electrode Model 3501 | Boston Scientific Corporation |
| 2021-01-27 | Z-0880-2021 | Class II | Abbott i-STAT CG8+ cartridges | Abbott Point Of Care Inc. |
| 2021-01-27 | Z-0881-2021 | Class II | Abbott i-STAT EG7+ cartridge-IVD | Abbott Point Of Care Inc. |
| 2021-01-27 | Z-0882-2021 | Class II | A | Biomet, Inc. |
| 2021-01-27 | Z-0883-2021 | Class II | A calculator/data processing module for clinical use is an electronic… | Roche Diagnostics Operations, Inc. |
| 2021-01-27 | Z-0884-2021 | Class II | Equinoxe Humeral Stem | Exactech, Inc. |
| 2021-01-20 | Z-0656-2021 | Class II | Artis zee/ zeego & Artis Q/ Q | Siemens Medical Solutions USA, Inc |
| 2021-01-20 | Z-0728-2021 | Class I | Lotus Edge Valve System | Boston Scientific Corporation |
| 2021-01-20 | Z-0729-2021 | Class I | Lotus Edge Valve System | Boston Scientific Corporation |
| 2021-01-20 | Z-0730-2021 | Class I | Lotus Edge Valve System | Boston Scientific Corporation |
| 2021-01-20 | Z-0734-2021 | Class I | Lotus Edge Valve System | Boston Scientific Corporation |
| 2021-01-20 | Z-0735-2021 | Class I | Lotus Edge Valve System | Boston Scientific Corporation |
| 2021-01-20 | Z-0736-2021 | Class I | Lotus Edge Valve System | Boston Scientific Corporation |
| 2021-01-20 | Z-0769-2021 | Class II | Remel Blood Agar/MacConkey Agar Bi-Plate | Remel Inc |
| 2021-01-20 | Z-0771-2021 | Class II | SOMATOM Force | Siemens Medical Solutions USA, Inc |
| 2021-01-20 | Z-0805-2021 | Class II | Uroskop Omnia | Siemens Medical Solutions USA, Inc |
| 2021-01-20 | Z-0806-2021 | Class II | Uroskop Omnia Max | Siemens Medical Solutions USA, Inc |
| 2021-01-20 | Z-0807-2021 | Class II | VERITAS Collagen Matrix | Baxter Healthcare Corporation |
| 2021-01-20 | Z-0808-2021 | Class II | Clerio Vision | Clerio Vision |
| 2021-01-20 | Z-0809-2021 | Class II | Disposable Humidification Flask | Cook Medical Llc |
| 2021-01-20 | Z-0810-2021 | Class II | EXOGEN Ultrasound Coupling Gel | Bioventus, LLC |
| 2021-01-20 | Z-0811-2021 | Class II | NaturaLyte Liquid Acid concentrate bottles | Fresenius Medical Care Holdings, Inc. |
| 2021-01-20 | Z-0812-2021 | Class II | NaturaLyte Liquid Acid concentrate bottles | Fresenius Medical Care Holdings, Inc. |
| 2021-01-20 | Z-0813-2021 | Class II | NaturaLyte Liquid Acid concentrate bottles | Fresenius Medical Care Holdings, Inc. |
| 2021-01-20 | Z-0814-2021 | Class II | NaturaLyte Liquid Acid concentrate bottles | Fresenius Medical Care Holdings, Inc. |
| 2021-01-20 | Z-0815-2021 | Class II | NaturaLyte Liquid Acid concentrate bottles | Fresenius Medical Care Holdings, Inc. |
| 2021-01-20 | Z-0816-2021 | Class II | NaturaLyte Liquid Acid concentrate bottles | Fresenius Medical Care Holdings, Inc. |
| 2021-01-20 | Z-0817-2021 | Class II | NaturaLyte Liquid Acid concentrate bottles | Fresenius Medical Care Holdings, Inc. |
| 2021-01-20 | Z-0818-2021 | Class II | NaturaLyte Liquid Acid concentrate bottles | Fresenius Medical Care Holdings, Inc. |
| 2021-01-20 | Z-0819-2021 | Class II | NaturaLyte Liquid Acid concentrate bottles | Fresenius Medical Care Holdings, Inc. |
| 2021-01-20 | Z-0820-2021 | Class II | NaturaLyte Liquid Acid concentrate bottles | Fresenius Medical Care Holdings, Inc. |
| 2021-01-20 | Z-0821-2021 | Class II | NaturaLyte Liquid Acid concentrate bottles | Fresenius Medical Care Holdings, Inc. |
| 2021-01-20 | Z-0822-2021 | Class II | NaturaLyte Liquid Acid concentrate bottles | Fresenius Medical Care Holdings, Inc. |
| 2021-01-20 | Z-0823-2021 | Class II | NaturaLyte Liquid Acid concentrate drums | Fresenius Medical Care Holdings, Inc. |
| 2021-01-20 | Z-0824-2021 | Class II | NaturaLyte Liquid Acid concentrate drums | Fresenius Medical Care Holdings, Inc. |