| HeartStart OnSite Defibrillator, HeartStart Home Defibrillator, HS1 SMART Pads, Adult, HS1 SMART Pads, Infant/Child (P160029/S013) | Philips Medical Systems, Inc. | 2021-08-10 |
| LIAISON XL MUREX HCV Ab, LIAISON XL MUREX Control HCV Ab (P190011/S004) | DiaSorin, Inc. | 2021-08-10 |
| Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, and Medtronic Evolut PRO+ System (P130021/S097) | Medtronic, Inc. | 2021-08-10 |
| LIAISON XL MUREX HBeAg, LIAISON XL MUREX Control HBeAg (P180048/S002) | DiaSorin, Inc. | 2021-08-10 |
| LIAISON XL MUREX Anti-HBs, LIAISON XL MUREX Control Anti-HBs and LIAISON XL MUREX Anti-HBs Verifiers (P180039/S004) | DiaSorin, Inc. | 2021-08-10 |
| cobas® EZH2 Mutation Test (P200014/S003) | Roche Molecular System, Inc. | 2021-08-10 |
| 13C-Spirulina Gastric Emptying Breath Test (GEBT) (P110015/S008) | Advanced Breath Diagnostics | 2021-08-10 |
| CardioMEMS HF System (P100045/S054) | ABBOTT MEDICAL | 2021-08-10 |
| LIAISON XL MUREX HBc IgM, LIAISON XL MUREX Control HBc IgM (P180045/S002) | DiaSorin, Inc. | 2021-08-10 |
| Durata, Optisure (P950022/S141) | ABBOTT MEDICAL | 2021-08-09 |
| Tendril STS, Tendril ST, Optisense (P960013/S120) | ABBOTT MEDICAL | 2021-08-09 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems (P160043/S052) | Medtronic Vascular | 2021-08-09 |
| M6-C Artificial Cervical Disc (P170036/S008) | Spinal Kinetics, LLC | 2021-08-06 |
| Blazer Open Irrigated Ablation Catheter (P150005/S066) | Boston Scientific Corp | 2021-08-06 |
| Arctic Front Advance Pro Cardiac Cryoablation Catheter, 23mm, US and Arctic Front Advance Pro Cardiac Cryoablation Cathe (P100010/S116) | Medtronic Cryocath, LP | 2021-08-06 |
| Lutonix 018 Drug Coated Balloon PTA Catheters (P170003/S019) | Lutonix | 2021-08-06 |
| LIPOSORBER LA-15 System (P910018/S029) | Kaneka Pharma America Corp. | 2021-08-06 |
| Lutonix 035 Drug Coated Balloon PTA Catheters (P130024/S038) | Lutonix | 2021-08-06 |
| Gel-One (P080020/S044) | Seikagaku Corp. | 2021-08-06 |
| SUPARTZ FX and VISCO-3 (P980044/S057) | Seikagaku Corp. | 2021-08-06 |
| VASCADE MVP VVCS (P120016/S028) | Cardiva Medical, Inc. | 2021-08-06 |
| LifeStent Vascular Stent Systems (P070014/S063) | Bard Peripheral Vascular, Inc. | 2021-08-05 |
| Axium Neurostimulator System (P150004/S051) | ABBOTT MEDICAL | 2021-08-05 |
| Bard Fluency Plus Endovascular Stent Graft (P130029/S010) | Bard Peripheral Vascular, Inc. | 2021-08-05 |
| Venovo Venous Stent System (P180037/S006) | Bard Peripheral Vascular, Inc. | 2021-08-05 |
| Lutonix 035 Drug Coated Balloon Catheter, Lutonix 018 Drug Coated Balloon Catheter (P130024/S041) | Lutonix | 2021-08-05 |
| CentriMag Circulatory Support System (P170038/S006) | Abbott | 2021-08-05 |
| RelayPro Thoracic Stent-Graft System (P200045) | Bolton Medical, Inc. | 2021-08-05 |
| IntellaNav ST Ablation Catheter, Blazer II Temperature Ablation Catheter, Blazer II HTD Temperature Ablation Catheter, a (P920047/S124) | Boston Scientific Corp | 2021-08-05 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System, Endurant II AUI Stent Graf (P100021/S094) | Medtronic Vascular | 2021-08-05 |
| Lutonix 018 Drug Coated Balloon Catheter (P170003/S023) | Lutonix | 2021-08-05 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S048) | Medtronic Vascular | 2021-08-05 |
| Blazer II XP Temperature Ablation Catheter, Blazer Prime XP Temperature Ablation Catheter, IntellaTip MiFi XP Temperatur (P020025/S129) | Boston Scientific | 2021-08-05 |
| Bard E-Luminexx and LifeStar Vascular Stent (P080007/S025) | Bard Peripheral Vascular, Inc. | 2021-08-05 |
| Blazer Open-Irrigated Ablation Catheter, IntellaNav Open-Irrigated Ablation Catheter, IntellaNav MiFi Open-Irrigated Abl (P150005/S061) | Boston Scientific Corp | 2021-08-05 |
| Covera Vascular Covered Stent (P170042/S010) | C.R. Bard, Inc. | 2021-08-05 |
| LeukoStrat CDx FLT3 Mutation Assay (P160040/S008) | Invivoscribe Technologies, Inc. | 2021-08-05 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S043) | Boston Scientific Corp | 2021-08-04 |
| Melody Transcatheter Pulmonary Valve (P140017/S019) | Medtronic, Inc. | 2021-08-03 |
| Rayner C-flex 570C, C-flex Aspheric 970C, 600C Aspheric Intraocular Lenses, RayOne Aspheric RAO600C, RayOne Spheric RAO1 (P060011/S028) | Rayner Intraocular Lenses , Ltd. | 2021-08-03 |
| Simplify Cervical Artificial Disc (P200022/S001) | Nuvasive, Inc. | 2021-08-03 |
| TactiCath Quartz Contact Force Ablation Catheter (P130026/S069) | St Jude Medical | 2021-08-03 |
| HeartWare Ventricular Assist System (P100047/S186) | Medtronic | 2021-08-03 |
| GORE VIATORR TIPS Endoprosthesis product family (P040027/S086) | W. L. Gore & Associates, Inc. | 2021-08-02 |
| GORE VIABAHN Endoprosthesis product family and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface product family (P130006/S082) | W. L. Gore & Associates, Inc. | 2021-08-02 |
| Organ Care System (OCS) Lung System (P160013/S008) | TransMedics, Inc. | 2021-08-02 |
| LCS Total Knee System (P830055/S270) | Depuy, Inc. | 2021-08-02 |
| GORE EXCLUDER AAA Endoprosthesis product family (P020004/S179) | W. L. Gore & Associates, Inc. | 2021-08-02 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis (P160021/S029) | W. L. Gore & Associates, Inc. | 2021-08-02 |
| GORE TAG Thoracic Endoprosthesis product family (P040043/S123) | W. L. Gore & Associates, Inc. | 2021-08-02 |
| GORE CARDIOFORM Septal Occluder and GORE CARDIOFORM ASD Occluder (P050006/S091) | W. L. Gore & Associates, Inc. | 2021-08-02 |
| GORE VIABAHN Endoprosthesis product family and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface product family (P040037/S143) | W. L. Gore & Associates, Inc. | 2021-08-02 |
| MitraClip NTR/XTR System, MitraClip G4System (P100009/S043) | ABBOTT MEDICAL | 2021-08-01 |
| OPTIMIZER Smart Mini System (P180036/S007) | Impulse Dynamics (Usa), Inc. | 2021-07-30 |
| SURGICEL NU-KNIT Absorbable Hemostat (N12159/S080) | ETHICON, Inc. | 2021-07-30 |
| NATRELLE Saline-Filled Breast Implants (P990074/S048) | Allergan | 2021-07-30 |
| ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA) (P200011) | Pillar Biosciences | 2021-07-30 |
| NATRELLE Silicone-Filled Breast Implants (P020056/S057) | Allergan | 2021-07-30 |
| FoundationOne CDx (F1CDx) (P170019/S026) | Foundation Medicine, Inc. | 2021-07-30 |
| XIENCE Skypoint Everolimus Eluting Coronary Stent System (P110019/S117) | Abbott Vascular | 2021-07-30 |
| Durata, Optisure (P950022/S140) | ABBOTT MEDICAL | 2021-07-29 |
| Praxis Extended RAS Panel (P160038/S019) | Illumina, Inc. | 2021-07-29 |
| Open Pivot Aortic Valved Graft (P990046/S059) | Medtronic Ats Medical, Inc. | 2021-07-29 |
| SenSight Diectional Lead Kit (P960009/S403) | Medtronic, Inc. | 2021-07-29 |
| Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S072) | ABBOTT MEDICAL | 2021-07-28 |
| Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S179) | ABBOTT MEDICAL | 2021-07-28 |
| ORSIRO Sirolimus Eluting Coronary Stent System (P170030/S018) | Biotronik AG | 2021-07-28 |
| LIPOSORBER LA-15 System (P910018/S031) | Kaneka Pharma America Corp. | 2021-07-28 |
| remede System (P160039/S006) | Respicardia | 2021-07-28 |
| Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) (P150004/S050) | ABBOTT MEDICAL | 2021-07-28 |
| TECNIS Family of 1-piece IOLs packaged in the Daisy Wheel Configuration (P980040/S141) | Johnson & Johnson Surgical Vision, Inc. | 2021-07-28 |
| NuDEL Delivery System (P150028/S005) | NuMED, Inc. | 2021-07-28 |
| Amplatzer Muscular VSD Occluder (P040040/S044) | ABBOTT MEDICAL | 2021-07-27 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems (P160043/S050) | Medtronic Vascular | 2021-07-27 |
| Amplatzer Duct Occluder, Amplatzer Duct Occluder II, Amplatzer Piccolo Occluder (P020024/S065) | ABBOTT MEDICAL | 2021-07-27 |
| Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology (P100018/S033) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2021-07-27 |
| Amplatzer Septal Occluder, Amplatzer Multi-Fenestrated Septal Occluder (P000039/S074) | ABBOTT MEDICAL | 2021-07-27 |
| PREVELEAK Surgical Sealant (P100030/S015) | Baxter Healthcare Corporation | 2021-07-27 |
| AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating (P050018/S031) | Spectranetics Corp. | 2021-07-27 |
| Amplatzer Patent Foramen Ovale (PFO) Occluder (P120021/S021) | ABBOTT MEDICAL | 2021-07-27 |
| ASSURE Wearable Cardioverter Defibrillator (WCD) System (P200037) | Kestra Medical Technologies, Inc. | 2021-07-27 |
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S003) | CooperVision, Inc. | 2021-07-26 |
| T-SPOT.TB Test (P070006/S017) | Oxford Immunotec, Ltd. | 2021-07-26 |
| Deep Brain Stimulation (DBS) (P140009/S067) | ABBOTT MEDICAL | 2021-07-26 |
| Spinal Cord Stimulation (SCS) (P010032/S172) | ABBOTT MEDICAL | 2021-07-26 |
| Cerene Cryotherapy Device (P180032/S008) | Channel Medsystems, Inc. | 2021-07-26 |
| NATRELLE Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (P040046/S031) | Allergan | 2021-07-26 |
| Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisil (P040029/S020) | Euclid Vision Corporation | 2021-07-26 |
| BioGlue Surgical Adhesive (P010003/S038) | Cryolife, Inc. | 2021-07-23 |
| Edwards INSPIRIS RESILIA Aortic Valve (P150048/S055) | Edwards Lifesciences, LLC | 2021-07-23 |
| VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM (P960040/S467) | Boston Scientific | 2021-07-23 |
| CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL (P010012/S541) | Boston Scientific Corp | 2021-07-23 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia MRI CRT-D, Compia MRI Quad CRT- (P010031/S752) | Medtronic Cardiac Rhythm Disease Management | 2021-07-22 |
| Mentor MemoryGel Silicone Gel-Filled Breast Implants (P030053/S064) | Mentor Corp. | 2021-07-22 |
| Mentor MemoryShape Breast Implants (P060028/S043) | Mentor Worldwide, LLC | 2021-07-22 |
| Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 IVL Catheter (P200039/S003) | Shockwave Medical, Inc. | 2021-07-22 |
| Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (P140031/S129) | Edwards Lifesciences, LLC | 2021-07-22 |
| Cerene Cryotherapy Device (P180032/S007) | Channel Medsystems, Inc. | 2021-07-22 |
| Exablate Model 4000 Type 1.0 and 1.1 System (Exablate Neuro) (P150038/S013) | Insightec | 2021-07-22 |
| HeartWare Ventricular Assist System (P100047/S185) | Medtronic | 2021-07-22 |