| Cologuard (P130017/S051) | Exact Sciences Corporation | 2022-04-13 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD, Impella 5.5 with SmartAssist (P140003/S097) | Abiomed, Inc. | 2022-04-12 |
| Barostim System (P180050/S004) | Cvrx, Inc. | 2022-04-12 |
| OrganOx metra® System (P200035/S001) | Organox Limited | 2022-04-12 |
| CardioMEMS HF System (P100045/S059) | ABBOTT MEDICAL | 2022-04-12 |
| SIR-Spheres Y-90 resin microspheres (P990065/S012) | Sirtex Medical, Inc. | 2022-04-12 |
| Impella RP, Impella RP with SmartAssist (P170011/S038) | Abiomed, Inc. | 2022-04-12 |
| PSW 2201.U/1 and NEO 2201.U/1 (P000009/S097) | Biotronik, Inc. | 2022-04-11 |
| CardioMEMS PA Sensor and Delivery System (P100045/S062) | ABBOTT MEDICAL | 2022-04-11 |
| Stellarex 0.035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (P160049/S017) | The Spectranetics Corp. | 2022-04-11 |
| PSW 2201.U/1 and NEO 2201.U/1 (P070008/S136) | Biotronik, Inc. | 2022-04-11 |
| HeartMate 3 Left Ventricular Assist System (P160054/S047) | ABBOTT MEDICAL | 2022-04-11 |
| PSW 2201.U/1 and NEO 2201.U/1 (P980023/S111) | Biotronik, Inc. | 2022-04-11 |
| PSW 2201.U/1 and NEO 2201.U/1 (P050023/S166) | Biotronik, Inc. | 2022-04-11 |
| Abbott RealTime IDH2 Amplification Reagent Kit, Abbott RealTime IDH2 Control Kit (P170005/S004) | Abbott Molecular, Inc. | 2022-04-11 |
| LeukoStrat CDx FLT3 Mutation Assay (P160040/S010) | Invivoscribe Technologies, Inc. | 2022-04-11 |
| HeartMate II Left Ventricular Assist System (P060040/S085) | ABBOTT MEDICAL | 2022-04-11 |
| PSW 2201.U/1 and NEO 2201.U/1 (P950037/S234) | Biotronik, Inc. | 2022-04-11 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt (P010031/S775) | Medtronic Cardiac Rhythm Disease Management | 2022-04-11 |
| Edwards Alterra Adaptive Prestent System (P200015/S019) | Edwards Lifesciences, LLC | 2022-04-08 |
| Harmony Transcatheter Pulmonary Valve (P200046/S008) | Medtronic, Inc. | 2022-04-08 |
| Impella 5.5 with SmartAssist (P140003/S093) | Abiomed, Inc. | 2022-04-08 |
| SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System(SLENDER IDS®), DIRECT Sirolimus-Eluting Coronary Ste (P210014/S001) | Advanced Bifurcation Systems, Inc. | 2022-04-08 |
| KONECT RESILIA Aortic Valved Conduit (P150048/S063) | Edwards Lifesciences, LLC | 2022-04-08 |
| Trulign® Toric Posterior Chamber Intraocular Lens (IOL) (P030002/S039) | Bausch & Lomb, Inc. | 2022-04-08 |
| Gambro Prismaflex TPE 2000 Set (P830063/S023) | Vantive US Healthcare, LLC | 2022-04-07 |
| Inspire Respiratory Sensing Lead and Inspire Stimulation Lead (P130008/S083) | Inspire Medical Systems | 2022-04-07 |
| IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P140010/S062) | Medtronic, Inc. | 2022-04-07 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System (P100021/S102) | Medtronic Vascular | 2022-04-07 |
| MarginProbe System (P110014/S012) | Dilon Medical Technologies, Ltd. | 2022-04-06 |
| Saluda Medical Evoke® SCS System (P190002/S002) | Saluda Medical Pty, Ltd. | 2022-04-06 |
| Exablate Model 4000 System (P150038/S019) | Insightec | 2022-04-06 |
| DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (P130005/S034) | Cardiovascular Systems, Inc. | 2022-04-06 |
| Master Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S419) | Medtronic, Inc. | 2022-04-06 |
| SURGIFOAM Absorbable Gelatin Sponge, SURGIFLO® Hemostatic Matrix, SURGIFOAM® Absorbable Gelatin Powder, SURGIFOAM® Absor (P990004/S054) | Ferrosan Meidcal Devices A/S | 2022-04-06 |
| Impella CP with SmartAssist (P140003/S092) | Abiomed, Inc. | 2022-04-05 |
| BioMimics 3D Vascular Stent System (P180003/S006) | Veryan Medical, Ltd. | 2022-04-05 |
| M6-C Artificial Cervical Disc (P170036/S010) | Spinal Kinetics, LLC | 2022-04-05 |
| Oxford Partial Knee System (P010014/S101) | Biomet Manufacturing Corp | 2022-04-04 |
| Zilver Vascular Stent (P050017/S019) | Cook Ireland, Ltd. | 2022-04-04 |
| Elecsys Anti-HBc II (P100031/S027) | Roche Diagnostics Corp. | 2022-04-04 |
| Elecsys Anti-HBc II (P100032/S021) | Roche Diagnostics Corp. | 2022-04-04 |
| Vercise Genus DBS System, Vercise Gevia DBS System, Vercise PC DBS System (P150031/S048) | Boston Scientific Corp | 2022-04-04 |
| HeartLight® X3 Catheter with Excalibur Balloon (P150026/S013) | Cardiofocus, Inc. | 2022-04-02 |
| Inspire Patient Remote (P130008/S082) | Inspire Medical Systems | 2022-04-01 |
| CentriMag Circulatory Support System (P170038/S009) | Abbott | 2022-04-01 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S777) | Medtronic Cardiac Rhythm Disease Management | 2022-04-01 |
| AMS 800 Artificial Urinary Sphincter, AMS 800 Artificial Urinary Sphincter with InhibiZone (P000053/S124) | Boston Scientific Corp | 2022-04-01 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S810) | Medtronic Cardiac Rhythm Disease Management | 2022-04-01 |
| Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web and Avitene Microfibrillar Collagen Hemostat (MCH) EndoAvit (P800002/S027) | C.R. Bard, Inc. | 2022-04-01 |
| AMS 700 Inflatable Penile Prosthesis, AMS 700 Inflatable Penile Prosthesis with InhibiZone (N970012/S190) | Boston Scientific Corp | 2022-04-01 |
| Trident Acetabular System: Trident Alumina Inserts (P000013/S020) | Howmedica Osteonics Corp. | 2022-04-01 |
| R3 Delta Ceramic Hip System (P150030/S019) | Smith & Nephew, Inc. | 2022-04-01 |
| Avitene Microfibrillar Collagen Hemostat (MCH) Flour, Avitene Microfibrillar Collagen Hemostat (MCH) SyringeAvitene, and (N17600/S034) | Davol Inc., Sub. C. R. Bard, Inc. | 2022-04-01 |
| LifePulse High Frequency Ventilator (P850064/S047) | Bunnell, Inc. | 2022-03-31 |
| Exablate Model 4000 System (P150038/S020) | Insightec | 2022-03-31 |
| CardioMEMS HF System (P100045/S061) | ABBOTT MEDICAL | 2022-03-31 |
| Suparts FX & Visco-3 (P980044/S059) | Seikagaku Corp. | 2022-03-31 |
| EDWARDS INTUITY Elite Valve (P150036/S060) | Edwards Lifesciences, LLC | 2022-03-31 |
| Carpentier-Edwards PERIMOUNT Magna Ease® Pericardial Aortic Bioprosthesis with ThermaFix tissue process (P860057/S206) | Edwards Lifesciences, LLC | 2022-03-31 |
| EnVeo PRO Delivery Catheter System, EnVeo R Delivery Catheter System, Evolut PRO+ Delivery Catheter System, Evolut FX De (P130021/S114) | Medtronic, Inc. | 2022-03-31 |
| Edwards Pericardial Aortic Bioprosthesis, INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Mitral Bioprosthesis (P150048/S061) | Edwards Lifesciences, LLC | 2022-03-31 |
| Aveir VR Leadless System (P150035) | ABBOTT MEDICAL | 2022-03-31 |
| WOLVERINE Coronary Cutting Balloon (P950020/S118) | Boston Scientific Corp | 2022-03-31 |
| PRISMAFLEX TPE2000 SET (P830063/S022) | Vantive US Healthcare, LLC | 2022-03-31 |
| GEL-ONE (P080020/S047) | Seikagaku Corp. | 2022-03-31 |
| TECNIS IOLs (P980040/S146) | Johnson & Johnson Surgical Vision, Inc. | 2022-03-30 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S357) | Medtronic Neuromodulation | 2022-03-30 |
| Wolverine Coronary Cutting Balloon (P950020/S120) | Boston Scientific Corp | 2022-03-30 |
| ROTAPRO Rotational Atherectomy System (P900056/S198) | Boston Scientific Corp | 2022-03-30 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S423) | Medtronic, Inc. | 2022-03-30 |
| Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus ELITE Everolimus-Eluting Platinum Chro (P110010/S203) | Boston Scientific Corp | 2022-03-30 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Coro (P150003/S084) | Boston Scientific Corporation | 2022-03-30 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S388) | Medtronic, Inc. | 2022-03-30 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S252) | Medtronic Neuromodulation | 2022-03-30 |
| Master Restore, Itrel®, Synergy® and Intellis Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris® Spinal (P840001/S513) | Medtronic Neuromodulation | 2022-03-30 |
| Agili-C (P210034) | Smith and Nephew, Inc. | 2022-03-29 |
| LD BG1 TN STR MRI IS1, LD BG1 TN J MRI IS1, LD BG1 PFRET STR MRI IS1, LD INGEVITY PLUS AF IS1 (P150012/S124) | Boston Scientific | 2022-03-29 |
| IMMULITE/IMMULITE 1000 PSA, IMMULITE 2000 PSA, IMMULITE/IMMULITE 1000 Third Generation PSA (P930027/S026) | Siemens Healthcare Diagnostics, Inc. | 2022-03-29 |
| Atellica® IM Alpha Fetoprotein (AFP) Assay (P930036/S019) | Siemens Healthcare Diagnostics, Inc. | 2022-03-29 |
| Atellica® IM Anti-Hepatitis B surface Antigen 2 (aHBs2) Assay (P100039/S015) | Siemens Healthcare Diagnostics, Inc. | 2022-03-29 |
| Atellica® IM Hepatitis B surface Antigen II (HBsll), Atellica® IM Hepatitis B surface Antigen 11 Confirmatory (HBsll Con (P110041/S013) | Siemens Corp. | 2022-03-29 |
| Atellica® IM Anti-Hepatitis B core Total (HBcT) Assay (P040004/S021) | Siemens Healthcare Diagnostics | 2022-03-29 |
| IMMULITE 2000 Anti-HBc (P010051/S015) | Siemens Healthcare Diagnostics Products, Ltd. | 2022-03-29 |
| Atellica® IM Prostate-Specific Antigen (PSA) Assay (P950021/S025) | Siemens Healthcare Diagnostics | 2022-03-29 |
| CapSure Sense Lead (P830061/S205) | Medtronic Cardiac Rhythm Disease Management | 2022-03-29 |
| CapSureFix Novus Lead (P930039/S240) | Medtronic, Inc. | 2022-03-29 |
| IMMULITE/IMMULITE 1000 AFP, IMMULITE 2000 AFP (P010007/S015) | Siemens Healthcare Diagnostics, Inc. | 2022-03-29 |
| Atellica® IM Hepatitis B core IgM (aHBcM) Assay (P030040/S021) | Siemens Healthcare Diagnostics | 2022-03-29 |
| Atellica® IM Hepatitis B e Antigen (HBeAg) Assay (P090024/S011) | Siemens Healthcare Diagnostics | 2022-03-29 |
| IMMULITE / IMMULITE 1000 Free PSA, IMMULITE 2000 Free PSA (P060005/S014) | Siemens Medical Solutions Diagnostics Limited | 2022-03-29 |
| Atellica® IM Anti-HBe2 Assay (P200017/S002) | Siemens Healthcare Diagnostics, Inc. | 2022-03-29 |
| Adapta, Versa, Sensia, Astra S DR MRI IPG, Astra S SR MRI IPG,Astra XT DR MRI IPG, Astra XT SR MRI IPG, Attesta DR MRI I (P980035/S711) | Medtronic, Inc. | 2022-03-29 |
| IMMULITE 2000 Anti-HBc IgM (P010053/S014) | Siemens Healthcare Diagnostics Products, Ltd. | 2022-03-29 |
| Atellica® IM Complexed PSA (cPSA) Assay (P990055/S024) | Siemens Healthcare Diagnostics | 2022-03-29 |
| LCS(R) Total Knee System (P830055/S285) | Depuy, Inc. | 2022-03-29 |
| Praxis Extended RAS Panel (P160038/S021) | Illumina, Inc. | 2022-03-28 |
| Flow Re-Direction Endoluminal Device (FRED) and FRED X System (P180027/S008) | MicroVention, Inc. | 2022-03-25 |
| AcrySof Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S142) | Alcon Laboratories, Inc. | 2022-03-25 |
| AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S102) | Alcon Research, Ltd. | 2022-03-25 |