| cobas HPV (P190028/S005) | Roche Molecular Systems, Inc. | 2021-06-02 |
| Vercise Deep Brain Stimulation Systems (P150031/S043) | Boston Scientific Corp | 2021-06-02 |
| cobas CMV (P160041/S033) | Roche Molecular Systems, Inc. | 2021-06-02 |
| Pulse Generator, Pacemaker, Implantable, with Cardiac Resynchronization (CRT-P) (P070008/S124) | Biotronik, Inc. | 2021-06-02 |
| KONECT RESILIA Aortic Valved Conduit (AVC) (P150048/S054) | Edwards Lifesciences, LLC | 2021-06-02 |
| cobas HCV (P150015/S043) | Roche Molecular Systems, Inc. | 2021-06-02 |
| cobas HBV (P150014/S041) | Roche Molecular Systems, Inc. | 2021-06-02 |
| Implantable System for Remodulin (P140032/S071) | Medtronic, Inc. | 2021-06-02 |
| Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber and Defibrillator, automatic (P050023/S155) | Biotronik, Inc. | 2021-06-02 |
| Pulse Generator, Pacemaker, Implantable with Cardiac Resynchronization (CRT-P) (P070008/S125) | Biotronik, Inc. | 2021-06-02 |
| CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S227) | Medtronic, Inc. | 2021-06-02 |
| Defibrillator, Automatic Implantable Crdioveter, with Cardiac Resynchronization (CRT-D), Defibrillator, Implantable Dual (P050023/S156) | Biotronik, Inc. | 2021-06-02 |
| Pulse Generator, Permanent, Implantable (P950037/S222) | Biotronik, Inc. | 2021-06-02 |
| Defibrillator, Implantable Dual-Chamber (P000009/S091) | Biotronik, Inc. | 2021-06-02 |
| SynchroMed Infusion System (P860004/S374) | Medtronic, Inc. | 2021-06-02 |
| Alinity m HCV (P190025/S006) | Abbott Molecular, Inc. | 2021-06-01 |
| TherOx Downstream System (P170027/S005) | Zoll Circulation, Inc. | 2021-06-01 |
| Woven EndoBridge (WEB) Aneurysm Embolization System (P170032/S008) | MicroVention, Inc. | 2021-06-01 |
| 7F Freezor Cardiac CryoablationCatheter and CCT.2 Cryoconsole System (P020045/S096) | Medtronic Cryocath, LP | 2021-06-01 |
| Alinity m HBV (P200013/S005) | Abbott Molecular, Inc. | 2021-06-01 |
| Juvederm Volbella XC (P110033/S053) | Allergan | 2021-05-28 |
| Epic and Epic Supra Tissue Heart Valves (P040021/S046) | ABBOTT MEDICAL | 2021-05-28 |
| therascreen KRAS RGQ PCR KIT (P110027/S012) | QIAGEN GmbH | 2021-05-28 |
| Guardant360 CDx (P200010/S002) | Guardant Health, Inc. | 2021-05-28 |
| FoundationOne CDx (F1CDx) (P170019/S021) | Foundation Medicine, Inc. | 2021-05-28 |
| DiamondTemp Ablation System (P200028/S004) | Medtronic, Inc. | 2021-05-28 |
| Simplify® Cervical Artificial Disc (2 Level) (P200022/S005) | Nuvasive, Inc. | 2021-05-28 |
| Endurant Stent Graft Family (P100021/S092) | Medtronic Vascular | 2021-05-28 |
| AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment (N970012/S187) | Boston Scientific Corp | 2021-05-27 |
| CareLink SmartSync Platform, CareLink SmartSync Host Application, CareLink SmartSync Common Application, CareLink SmartS (P890003/S444) | Medtronic, Inc. | 2021-05-27 |
| Promus Premier and Promus Elite Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S193) | Boston Scientific Corp | 2021-05-27 |
| SYNERGY, SYNERGY XD and SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S074) | Boston Scientific Corporation | 2021-05-27 |
| Micra Transcatheter Pacing System, Micra AV TPS (P150033/S106) | Medtronic, Inc. | 2021-05-27 |
| CareLink SmartSync Viva Consulta Syncra Advisa Ensura Application (P010015/S470) | Medtronic, Inc. | 2021-05-27 |
| CareLink SmartSync Micra VR/AV Application (P150033/S096) | Medtronic, Inc. | 2021-05-27 |
| Alair Bronchial Thermoplasty System (P080032/S018) | Boston Scientific Corp | 2021-05-27 |
| AMS 800 Series Product Line/Artificial Urinary Sphincter with and without InhibiZone Treatment (P000053/S120) | Boston Scientific Corp | 2021-05-27 |
| CareLink SmartSync Viva Consulta Syncra Advisa Ensura Application (P980035/S677) | Medtronic, Inc. | 2021-05-27 |
| CareLink SmartSync Viva Consulta Syncra Advisa Ensura Application (P980016/S775) | Medtronic Cardiac Rhythm Disease Management | 2021-05-27 |
| CareLink SmartSync Viva Consulta Syncra Advisa Ensura Application (P010031/S737) | Medtronic Cardiac Rhythm Disease Management | 2021-05-27 |
| Gel-One (P080020/S043) | Seikagaku Corp. | 2021-05-26 |
| RHA 2, RHA 3, RHA 4 Dermal Fillers (P170002/S017) | Teoxane S.A. | 2021-05-26 |
| CapSureFix Novus Lead (P930039/S226) | Medtronic, Inc. | 2021-05-26 |
| Simplify® Cervical Artificial Disc (One-Level) (P200022/S006) | Nuvasive, Inc. | 2021-05-26 |
| AMS 700 Inflatable Penile Prosthesis (N970012/S186) | Boston Scientific Corp | 2021-05-26 |
| INCRAFT AAA Stent Graft System (P150002/S010) | Cordis US Corporation | 2021-05-26 |
| Axonics Sacral Neuromodulation (SNM) System for Urinary Control (P180046/S037) | Boston Scientific Corporation | 2021-05-25 |
| Axonics Sacral Neuromodulation (SNM) System for Bowel Control (P190006/S037) | Boston Scientific Corporation | 2021-05-25 |
| DiamondTemp Radiofrequency (RF) Generator (P200028/S003) | Medtronic, Inc. | 2021-05-25 |
| Flow Re-Direction Endoluminal Device (FRED) System (P180027/S004) | MicroVention, Inc. | 2021-05-25 |
| DUROLANE (P170007/S009) | Bioventus, LLC | 2021-05-25 |
| Activa, Percept and SenSight Deep Brain Stimulation Therapy System (P960009/S391) | Medtronic, Inc. | 2021-05-25 |
| SUPARTZ device family, SUPARTZ FX and VISCO-3 (P980044/S056) | Seikagaku Corp. | 2021-05-24 |
| HeartWare Ventricular Assist System (P100047/S179) | Medtronic | 2021-05-24 |
| Optune System (P100034/S028) | Novocure, GmbH | 2021-05-24 |
| Neuropace RNS System (P100026/S085) | NeuroPace, Inc. | 2021-05-24 |
| WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System (P130013/S042) | Boston Scientific Corp | 2021-05-21 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S024) | Medinol, Ltd. | 2021-05-21 |
| Rapid fFN for the TLiIQ System (P920048/S019) | Hologic, Inc. | 2021-05-21 |
| TactiSys Quartz Equipment (P130026/S073) | St Jude Medical | 2021-05-21 |
| Resolute Integrity RX Zotarolimus-Eluting Coronary Stent System (P110013/S111) | Medtronic Vascular | 2021-05-21 |
| Integrity Coronary Stent System Rx and OTW (P030009/S103) | Medtronic, Ireland | 2021-05-21 |
| IN.PACT AV DCB (P190008/S014) | Medtronic Vascular, Inc. | 2021-05-21 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System (P160043/S047) | Medtronic Vascular | 2021-05-21 |
| Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG (P980035/S682) | Medtronic, Inc. | 2021-05-21 |
| Guardant360 CDx (P200010/S001) | Guardant Health, Inc. | 2021-05-21 |
| IN.PACT Admiral DCB Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S060) | Medtronic, Inc. | 2021-05-21 |
| Structural Heart Delivery Catheter Systems & Loading systems (P130021/S092) | Medtronic, Inc. | 2021-05-21 |
| Praxis Extended RAS Panel (P160038/S020) | Illumina, Inc. | 2021-05-21 |
| Senza Spinal Cord Stimulation (SCS) System (P130022/S034) | Nevro Corporation | 2021-05-21 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant II AUI Stent Graft System, Endurant IIs Stent Graf (P100021/S091) | Medtronic Vascular | 2021-05-21 |
| Valiant Navion Thoracic Stent Graft System, Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S047) | Medtronic Vascular | 2021-05-21 |
| iSert Preloaded System (P080004/S031) | Hoya Surgical Optics, Inc. | 2021-05-21 |
| Micra Transcatheter Pacemaker System, Micra Transcatheter Pacemaker System, Micra AV application software (P150033/S105) | Medtronic, Inc. | 2021-05-21 |
| Harmony Transcatheter Pulmonary System (P200046/S002) | Medtronic, Inc. | 2021-05-21 |
| Venaseal Closure System (P140018/S025) | Medtronic Vascular, Inc. | 2021-05-21 |
| Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S128) | CooperVision, Inc. | 2021-05-20 |
| BD PrepStain System (P970018/S038) | Bd Diagnostic Systems | 2021-05-20 |
| VENTANA HER2 Dual ISI-I DNA Probe Cocktail (P190031/S002) | Ventana Medical Systems, Inc. | 2021-05-20 |
| PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody (P990081/S044) | Ventana Medical Systems, Inc. | 2021-05-20 |
| VENTANA PD-LI (SP142) Assay (P160002/S014) | Ventana Medical Systems, Inc. | 2021-05-20 |
| PATI-IWAY Anti-c-KIT (9.7) Primary Antibody (P020055/S024) | Ventana Medical Systems, Inc. | 2021-05-20 |
| VENTANA PD-LI (SP263) Assay (P160046/S009) | Ventana Medical Systems, Inc. | 2021-05-20 |
| VENTANA ALK (D5F3) CDx Assay (P140025/S015) | Ventana Medical Systems, Inc. | 2021-05-20 |
| INFORM HER2 Dual ISH DNA Probe Cocktail (P100027/S034) | Ventana Medical Systems, Inc. | 2021-05-20 |
| CINtec PLUS Cytology (P190024/S003) | Ventana Medical Systems, Inc. | 2021-05-20 |
| DiamondTemp Ablation Catheters (P200028/S006) | Medtronic, Inc. | 2021-05-19 |
| Axonics Sacral Neuromodulation System (P180046/S024) | Boston Scientific Corporation | 2021-05-19 |
| X Series Advanced Devices (P160022/S028) | ZOLL Medical Corporation | 2021-05-19 |
| Falope Ring Band and Applicator Systems (P870076/S027) | Gyrus Acmi, Inc. | 2021-05-19 |
| LifeStent Vascular Stent Systems (P070014/S060) | Bard Peripheral Vascular, Inc. | 2021-05-19 |
| Axonics Sacral Neuromodulation System (P190006/S024) | Boston Scientific Corporation | 2021-05-19 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S071) | St Jude Medical | 2021-05-18 |
| FlexAbility and FlexAbility SE Ablation Catheter (P110016/S076) | ABBOTT MEDICAL | 2021-05-18 |
| Therapy Cool Path (P060019/S053) | Irvine Biomedical, Inc. | 2021-05-18 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve (P980016/S783) | Medtronic Cardiac Rhythm Disease Management | 2021-05-18 |
| 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/S745) | Medtronic Cardiac Rhythm Disease Management | 2021-05-18 |
| LiveWire TC Ablation Catheter and Safire Ablation Catheter (P960016/S087) | St Jude Medical | 2021-05-18 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, (P980035/S681) | Medtronic, Inc. | 2021-05-18 |
| SYNERGY Everolimus Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire) (P150003/S075) | Boston Scientific Corporation | 2021-05-18 |