| cobas HBV (P150014/S039) | Roche Molecular Systems, Inc. | 2020-10-07 |
| cobas CMV (P160041/S031) | Roche Molecular Systems, Inc. | 2020-10-07 |
| cobas HCV (P150015/S041) | Roche Molecular Systems, Inc. | 2020-10-07 |
| Covera Vascular Covered Stent (P170042/S005) | C.R. Bard, Inc. | 2020-10-07 |
| Access Hybritech Free PSA Reagents on the Access Immunoassay Systems (P970038/S042) | Beckman Coulter, Inc. | 2020-10-07 |
| ZOLL AED Plus and ZOLL Fully Automatic AED Plus (P160015/S006) | ZOLL Medical Corporation | 2020-10-07 |
| Access AFP Reagents on the Access Immunoassay Systems (P980041/S047) | Beckman Coulter, Inc. | 2020-10-07 |
| Cologuard (P130017/S043) | Exact Sciences Corporation | 2020-10-07 |
| LIFEPAK CR2 Defibrillator (P170018/S009) | Physio-Control, Inc. | 2020-10-07 |
| VisuMax Femtosecond Laser (P150040/S006) | Carl Zeiss Meditec, Inc. | 2020-10-07 |
| LOTUS Edge Valve System (P180029/S027) | Boston Scientific Corporation | 2020-10-07 |
| Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S054) | Beckman Coulter, Inc. | 2020-10-07 |
| HeartWare Ventricular Assist System (P100047/S172) | Medtronic | 2020-10-06 |
| Adapta, Versa, Sensia IPG and Relia IPG (P980035/S643) | Medtronic, Inc. | 2020-10-06 |
| Acculink Carotid Stent System (P040012/S060) | Abbott Vascular | 2020-10-06 |
| AMPLATZER PFO Occluder (P120021/S016) | ABBOTT MEDICAL | 2020-10-06 |
| Zephyr Endobronchial Valve (EBV) System (P180002/S015) | Pulmonx Corporation | 2020-10-06 |
| AMPLATZER Duct Occluder (P020024/S061) | ABBOTT MEDICAL | 2020-10-06 |
| AMPLATZER Septal Occluder and AMPLATZER Multi-Fenestrated Septal (Cribriform) Occluder (P000039/S071) | ABBOTT MEDICAL | 2020-10-06 |
| AMPLATZER Muscular VSD Occluder (P040040/S041) | ABBOTT MEDICAL | 2020-10-06 |
| CERAMAX Ceramic Total Hip System (P070026/S076) | DePuy Orthopaedics, Inc. | 2020-10-05 |
| Valiant Navion Thoracic Stent Graft System (P100040/S041) | Medtronic Vascular | 2020-10-05 |
| Resolute Onyx Coronary Stent System (P160043/S037) | Medtronic Vascular | 2020-10-05 |
| Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S117) | CooperVision, Inc. | 2020-10-05 |
| Resolute Integrity Rapid Exchange Coronary Stent System (P110013/S103) | Medtronic Vascular | 2020-10-05 |
| CoreValve Evolut R and Evolut PRO System (P130021/S080) | Medtronic, Inc. | 2020-10-05 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P140010/S051) | Medtronic, Inc. | 2020-10-05 |
| Integrity Coronary Stent System (P030009/S097) | Medtronic, Ireland | 2020-10-05 |
| Endurant II/IIs Stent Graft System (P100021/S083) | Medtronic Vascular | 2020-10-05 |
| Edwards Commander Delivery System (P140031/S120) | Edwards Lifesciences, LLC | 2020-10-05 |
| Pipeline Flex Embolization Device (P100018/S024) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2020-10-05 |
| GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S118) | W. L. Gore & Associates, Inc. | 2020-10-05 |
| LIFEPAK CR2 Automated External Defibrillator (P170018/S010) | Physio-Control, Inc. | 2020-10-04 |
| Tryton Side Branch Stent (P150039/S005) | Poseidon Medical, Inc. | 2020-10-04 |
| RADIESSE Injectable Implant, RADIESSE Hands, and RADIESSE (+) Lidocaine Dermal Filler (P050052/S120) | Merz North America, Inc. | 2020-10-02 |
| Rapid fFN for the TLiIQ System (P920048/S018) | Hologic, Inc. | 2020-10-02 |
| AcrySof Posterior Chamber Intraocular Lens (P930014/S133) | Alcon Laboratories, Inc. | 2020-10-02 |
| BELOTERO BALANCE Dermal Filler, BELOTERO BALANCE (+) Lidocaine Dermal Filler (P090016/S037) | Merz North America, Inc. | 2020-10-02 |
| RADIESSE Injectable Implant (P050037/S102) | Merz North America, Inc. | 2020-10-02 |
| COAPTITE Injectable Implant (P040047/S056) | Merz North America, Inc. | 2020-10-02 |
| AcrySof IQ ReSTOR Posterior Chamber Intraocular Lens (P040020/S096) | Alcon Research, Ltd. | 2020-10-02 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel) (P080025/S211) | Medtronic Neuromodulation | 2020-10-01 |
| PG VALITUDE CRT-P, PG VISIONIST CRT-P (P030005/S202) | Guidant Corp. | 2020-10-01 |
| Amvisc and Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (P810025/S040) | Bausch & Lomb, Inc. | 2020-10-01 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary) (P970004/S316) | Medtronic Neuromodulation | 2020-10-01 |
| Covera Vascular Covered Stent (P170042/S008) | C.R. Bard, Inc. | 2020-10-01 |
| Biofinity Sphere and Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S106) | CooperVision, Inc. | 2020-10-01 |
| Restylane Injectable Gels (P040024/S117) | Q-Med AB | 2020-10-01 |
| SmartAblate Irrigation Tubing Set (P990071/S045) | Biosense Webster, Inc. | 2020-10-01 |
| Activa Deep Brain Stimulation Therapy System (P960009/S384) | Medtronic, Inc. | 2020-10-01 |
| S-ICD GEN 2, S-ICD EMBLEM MRI (P110042/S146) | Boston Scientific Corporation | 2020-10-01 |
| Perclose ProGlide Suture-Mediated Closure System (P960043/S109) | Abbott Vascular, Inc. | 2020-10-01 |
| ICD ORIGEN CRT-D, MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, ICD AUTOGEN CRT-D, VIGILANT CR (P010012/S523) | Boston Scientific Corp | 2020-10-01 |
| Titan Inflatable Penile Prosthesis (P000006/S057) | Coloplast Corp. | 2020-10-01 |
| PG ESSENTIO SR, PG ESSENTIO DR, PG PROPONENT SR, PG PROPONENT DR, PG ACCOLADE SR, PG ACCOLADE DR, PG ALTRUA 2 SR, PG ALT (N970003/S256) | Boston Scientific Corp | 2020-10-01 |
| Venovo Venous Stent System (P180037/S004) | Bard Peripheral Vascular, Inc. | 2020-10-01 |
| PG ESSENTIO MRI SR, PG ESSENTIO MRI DR, PG PROPONENT MRI SR, PG PROPONENT MRI DR, PG ACCOLADE MRI SR, PG ACCOLADE MRI D (P150012/S101) | Boston Scientific | 2020-10-01 |
| ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, ICD ORIGEN VR, ICD ORIGEN DR (P960040/S454) | Boston Scientific | 2020-10-01 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S470) | Medtronic Neuromodulation | 2020-10-01 |
| Precision Montage and Precision Montage MRI Spinal Cord Stimulator Systems (P030017/S342) | Boston Scientific Corp | 2020-09-30 |
| Supera Peripheral Stent System (P120020/S024) | Abbott Vascular (Idef Technologies Inc) | 2020-09-30 |
| 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/S716) | Medtronic Cardiac Rhythm Disease Management | 2020-09-30 |
| 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/S642) | Medtronic, Inc. | 2020-09-30 |
| Trident Ceramic System (P000013/S017) | Howmedica Osteonics Corp. | 2020-09-30 |
| 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/S755) | Medtronic Cardiac Rhythm Disease Management | 2020-09-30 |
| THERMOCOOL SMARTTOUCH® SF Catheter (P030031/S100) | Biosense Webster, Inc. | 2020-09-30 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S450) | Medtronic, Inc. | 2020-09-30 |
| ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (P160031/S003) | Fujifilm Medical Systems U.S.A, Inc. | 2020-09-30 |
| HeartWare Ventricular Assist System (P100047/S171) | Medtronic | 2020-09-30 |
| LCS Total Knee System (P830055/S252) | Depuy, Inc. | 2020-09-29 |
| Brava CRT-D, Brava Quad CRT-D, Viva Quad CRT-D, Viva Quad S CRT-D, Viva Quad XT CRT-D, Viva S CRT-D, and Viva XT CRT-D (P010031/S708) | Medtronic Cardiac Rhythm Disease Management | 2020-09-29 |
| Clareon Aspheric Hydrophobic Acrylic IOL with the AutonoMe Automated Pre-loaded Delivery System, Clareon Toric Aspheric (P190018/S006) | Alcon Laboratories, LLC | 2020-09-29 |
| Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Mirro MRI DR ICD, M (P980016/S748) | Medtronic Cardiac Rhythm Disease Management | 2020-09-29 |
| Rotablator Rotational Atherectomy System and ROTAPRO Rotational Atherectomy System (P900056/S188) | Boston Scientific Corp | 2020-09-29 |
| X Series, Propaq MD, and R Series (P160022/S022) | ZOLL Medical Corporation | 2020-09-29 |
| Micra TPS (P150033/S077) | Medtronic, Inc. | 2020-09-29 |
| Rotablator Rotational Atherectomy System and ROTAPRO Rotational Atherectomy System (P900056/S189) | Boston Scientific Corp | 2020-09-29 |
| X Series and Propaq MD (P160022/S020) | ZOLL Medical Corporation | 2020-09-29 |
| Inspire IV IPG (P130008/S060) | Inspire Medical Systems | 2020-09-29 |
| NeuroPace RNS System (P100026/S084) | NeuroPace, Inc. | 2020-09-28 |
| Tack Endovascular System (6F) (P180034/S003) | Philips Image Guided Therapy Corporation | 2020-09-28 |
| Bausch + Lomb PureVision (balafilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses (P980006/S030) | Bausch & Lomb, Inc. | 2020-09-28 |
| Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses (P170035/S009) | Bausch and Lomb, Inc., | 2020-09-28 |
| Tack Endovascular System (4F) (P190027/S001) | Philips Image Guided Therapy Corporation (Formerly Intact) | 2020-09-28 |
| Edwards Commander Delivery System (P140031/S119) | Edwards Lifesciences, LLC | 2020-09-25 |
| Rotablator Rotational Atherectomy System (P900056/S190) | Boston Scientific Corp | 2020-09-25 |
| MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE (P980035/S641) | Medtronic, Inc. | 2020-09-25 |
| Edwards Commander Delivery System (P200015/S004) | Edwards Lifesciences, LLC | 2020-09-25 |
| AudioStream and AudioKey 2.0 (P000025/S117) | Med-El Corp. | 2020-09-25 |
| Covera Vascular Covered Stent (P170042/S007) | C.R. Bard, Inc. | 2020-09-25 |
| Mi1260 SONATA 2 Cochlear Implant and Mi1250 SYNCHRONY 2 (PIN) Cochlear Implant (P000025/S114) | Med-El Corp. | 2020-09-25 |
| RF Conductr, RF Contactr, RF Marinr, and RF Enhancr II (P930029/S067) | Medtronic, Inc. | 2020-09-25 |
| SURGIFOAM Absorbable Gelatin Sponge, U.S.P. (P990004/S043) | Ferrosan Meidcal Devices A/S | 2020-09-25 |
| FINELINE II Steroid-Eluting Pacing Leads (P960004/S091) | Boston Scientific | 2020-09-25 |
| Arista AH Absorbable Hemostatic (P050038/S036) | Davol, Inc. | 2020-09-25 |
| NexGen LPS-Flex and LPS Mobile Bearing Knee System (P060037/S068) | Zimmer, Inc. | 2020-09-25 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System (P160043/S038) | Medtronic Vascular | 2020-09-25 |
| LCS Total Knee System (P830055/S256) | Depuy, Inc. | 2020-09-25 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent System (P110013/S104) | Medtronic Vascular | 2020-09-25 |
| LifeStent 5F Vascular Stent Systems (P070014/S061) | Bard Peripheral Vascular, Inc. | 2020-09-25 |