| GELSYN-3 (P110005/S004) | Ibsa Institut Biochimique SA | 2020-07-10 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S054) | Coloplast Corp. | 2020-07-10 |
| THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter and THERMOCOOL SMARTTOUCH Navigation Catheter (P040036/S075) | Biosense Webster, Inc. | 2020-07-10 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S033) | Boston Scientific Corp | 2020-07-10 |
| THERMOCOOL SMARTTOUCH SF Uni-Directional Navigation Catheter and THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Cath (P030031/S107) | Biosense Webster, Inc. | 2020-07-10 |
| KONECT RESILIA Aortic Valved Conduit AVC (P150048/S029) | Edwards Lifesciences, LLC | 2020-07-10 |
| Impella RP System (P170011/S024) | Abiomed, Inc. | 2020-07-10 |
| Axonics Sacral Neuromodulation System (P190006/S017) | Boston Scientific Corporation | 2020-07-10 |
| Adherus AutoSpray ET Dural Sealant (P130014/S007) | Stryker Leibinger GmbH & Co KG | 2020-07-10 |
| CapSureFix Novus Lead (P930039/S213) | Medtronic, Inc. | 2020-07-10 |
| CapSureFix MRI Lead (P090013/S307) | Medtronic, Inc. | 2020-07-10 |
| CapSure Sense Lead (P830061/S183) | Medtronic Cardiac Rhythm Disease Management | 2020-07-10 |
| Infuse Bone Graft/Medtronic Interbody Fusion Device (P000058/S078) | Medtronic Sofamor Danek USA, Inc. | 2020-07-10 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S029) | ABBOTT MEDICAL | 2020-07-10 |
| Axonics Sacral Neuromodulation System (P180046/S017) | Boston Scientific Corporation | 2020-07-10 |
| Infuse Bone Graft (P050053/S050) | Medtronic, Inc. | 2020-07-10 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.5 with SmartAssist, Impella 5.0, and Impella LD Systems (P140003/S073) | Abiomed, Inc. | 2020-07-10 |
| Infuse Bone Graft (P000054/S059) | Medtronic Sofamor Danek USA, Inc. | 2020-07-10 |
| Ovation iX Abdominal Stent Graft System (P120006/S036) | Endologix, LLC | 2020-07-09 |
| Gore TAG Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S115) | W. L. Gore & Associates, Inc. | 2020-07-09 |
| DEFLUX Injectable Gel (P000029/S089) | Palette Life Sciences | 2020-07-09 |
| Solesta Injectable Gel (P100014/S027) | Palette Life Sciences | 2020-07-09 |
| HeartWare HVAD System (P100047/S132) | Medtronic | 2020-07-09 |
| Amplatzer Piccolo Occluder (P020024/S062) | ABBOTT MEDICAL | 2020-07-09 |
| LIFEPAK Automated External Defibrillators (AEDs) (P160026/S018) | Physio-Control, Inc. | 2020-07-09 |
| SURGIFOAM Absorbable Gelatin Sponge, U.S.P. (P990004/S040) | Ferrosan Meidcal Devices A/S | 2020-07-08 |
| Axonics Sacral Neuromodulation System (P190006/S018) | Boston Scientific Corporation | 2020-07-08 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S440) | Medtronic, Inc. | 2020-07-08 |
| Cerene Cryotherapy Device (P180032/S001) | Channel Medsystems, Inc. | 2020-07-08 |
| 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/S629) | Medtronic, Inc. | 2020-07-08 |
| Axonics Sacral Neuromodulation System (P180046/S018) | Boston Scientific Corporation | 2020-07-08 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, and Crome MRI CRT-D (P010031/S704) | Medtronic Cardiac Rhythm Disease Management | 2020-07-08 |
| CERAMAX Ceramic Total Hip System (P070026/S073) | DePuy Orthopaedics, Inc. | 2020-07-08 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, and Crome MRI ICD (P980016/S743) | Medtronic Cardiac Rhythm Disease Management | 2020-07-08 |
| ZOLL R Series (P160022/S017) | ZOLL Medical Corporation | 2020-07-07 |
| LATITUDE Programming System (P910077/S178) | Boston Scientific | 2020-07-07 |
| EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) System (P110042/S137) | Boston Scientific Corporation | 2020-07-07 |
| ACUITY X4 (P010012/S520) | Boston Scientific Corp | 2020-07-07 |
| RELIANCE 4-FRONT (P910073/S157) | Boston Scientific | 2020-07-07 |
| LCS Total Knee System (P830055/S250) | Depuy, Inc. | 2020-07-07 |
| Axonics SNM System (P190006/S016) | Boston Scientific Corporation | 2020-07-02 |
| Advia Centaur PSA Immunoassay and Atellica IM PSA Immunoassay (P950021/S019) | Siemens Healthcare Diagnostics | 2020-07-02 |
| Nucleus 22 Cochlear Implant Systems (P840024/S092) | Cochlear Americas | 2020-07-02 |
| Nucleus 24 Cochlear Implant Systems (P970051/S193) | Cochlear Americas | 2020-07-02 |
| Falope Ring Bands (P870076/S025) | Gyrus Acmi, Inc. | 2020-07-02 |
| GORE CARDIOFORM ASD Occluder (P050006/S083) | W. L. Gore & Associates, Inc. | 2020-07-02 |
| Nucleus Hybrid Cochlear Implant (P130016/S041) | Cochlear Americas | 2020-07-02 |
| LifeVest Wearable Defibrillator (P010030/S140) | Zoll Manufacturing Corporation | 2020-07-02 |
| Advia Centaur AFP Immunoassay and Atellica IM AFP Immunoassay (P930036/S012) | Siemens Healthcare Diagnostics, Inc. | 2020-07-02 |
| Axonics SNM System (P180046/S016) | Boston Scientific Corporation | 2020-07-02 |
| iStent inject W Trabecular Micro-Bypass System (P170043/S005) | Glaukos Corporation | 2020-07-02 |
| Adiva Centaur Complexed PSA (cPSA) Immunoassay and Atellica IM cPSA Immunoassay (P990055/S019) | Siemens Healthcare Diagnostics | 2020-07-02 |
| Nucleus Auditory Brainstem Implant (P000015/S041) | Cochlear Americas | 2020-07-02 |
| Axonics Sacral Neuromodulation System (P190006/S011) | Boston Scientific Corporation | 2020-07-01 |
| Restylane Refyne, Restylane Defyne, and Restylane Kysse Injectable Gels (P140029/S026) | Q-Med AB | 2020-07-01 |
| HeartLight Catheter and HeartLight Console (P150026/S011) | Cardiofocus, Inc. | 2020-07-01 |
| Axonics Sacral Neuromodulation System (P180046/S011) | Boston Scientific Corporation | 2020-07-01 |
| Mentor MemoryShape Breast Implants (P060028/S033) | Mentor Worldwide, LLC | 2020-07-01 |
| MENTOR MEMORYSHAPE BREAST IMPLANTS (P060028/S032) | Mentor Worldwide, LLC | 2020-07-01 |
| Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S427) | Medtronic Neuromodulation | 2020-07-01 |
| Infinity DBS IPG (P140009/S058) | ABBOTT MEDICAL | 2020-07-01 |
| Propel Mini Sinus Implant (P100044/S046) | Intersect Ent. | 2020-07-01 |
| REBEL Platinum Chromium Coronary Stent System Monorail and Over-the-Wire (P130030/S069) | Boston Scientific Corp | 2020-07-01 |
| Proclaim DRG IPG (P150004/S037) | ABBOTT MEDICAL | 2020-07-01 |
| Proclaim family of SCS IPG (P010032/S162) | ABBOTT MEDICAL | 2020-07-01 |
| Mara Water Vapor Ablation System, Mara Water vapor Probe, Mara Console (P160047/S011) | CooperSurgical, Inc. | 2020-07-01 |
| ADEPT Adhesion Reduction Solution (P050011/S007) | Baxter Healthcare Corp | 2020-07-01 |
| Assurity MRI, Endurity MRI family of Pacemakers (P140033/S050) | ABBOTT MEDICAL | 2020-06-30 |
| Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs (P910023/S423) | ABBOTT MEDICAL | 2020-06-30 |
| HercepTest (P980018/S025) | Agilent Technologies Singapore (International) Pte , Ltd. | 2020-06-30 |
| Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ (P030054/S374) | ABBOTT MEDICAL | 2020-06-30 |
| Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S178) | ABBOTT MEDICAL | 2020-06-30 |
| Microny family of Pacemakers (P970013/S082) | ABBOTT MEDICAL | 2020-06-30 |
| Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S308) | ABBOTT MEDICAL | 2020-06-30 |
| Durata And Optisure HV Passive Steroid Eluting Cardiac Leads (P950022/S134) | ABBOTT MEDICAL | 2020-06-30 |
| Vercise Deep Brain Stimulation (DBS) System (P150031/S031) | Boston Scientific Corp | 2020-06-29 |
| Apollo Onyx Delivery Micro Catheter (P030004/S024) | Ev3 Neurovascular | 2020-06-29 |
| LINX Reflux Management System (P100049/S027) | Torax Medical | 2020-06-29 |
| Pipeline Flex Embolization Device (P100018/S027) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2020-06-29 |
| Thermocool Smarttouch SF (P030031/S106) | Biosense Webster, Inc. | 2020-06-26 |
| Impella 2.5, CP, and CP with SmartAssist (P140003/S065) | Abiomed, Inc. | 2020-06-26 |
| EnVeo R, EnVeo PRO and Evolut PRO+ Delivery Catheter Systems and Loading Systems of the Evolut R/PRO/PRO+ Systems (P130021/S078) | Medtronic, Inc. | 2020-06-26 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S025) | ABBOTT MEDICAL | 2020-06-26 |
| Lutonix 035 DCB PTA Catheter Balloon (P130024/S035) | Lutonix | 2020-06-26 |
| Thermocool Smarttouch (P040036/S074) | Biosense Webster, Inc. | 2020-06-26 |
| Accent MRI Pacemaker (P140033/S054) | ABBOTT MEDICAL | 2020-06-26 |
| HeartMate II Left Ventricular Assist System (LVAS) (P060040/S076) | ABBOTT MEDICAL | 2020-06-26 |
| Ceramax Ceramic Total Hip System (P070026/S072) | DePuy Orthopaedics, Inc. | 2020-06-26 |
| MiniMed 630G System with Smart Guard (P150001/S086) | Medtronic Minimed | 2020-06-25 |
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S006) | CooperVision, Inc. | 2020-06-25 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P190008/S003) | Medtronic Vascular, Inc. | 2020-06-25 |
| Wallstent (Tips) Endoprosthesis With Unistep Plus Delivery System (P930031/S067) | Boston Scientific Corp | 2020-06-25 |
| Guardian Connect System (P160007/S036) | Medtronic Minimed | 2020-06-25 |
| Wallstent Iliac Endoprosthesis with Unistep Plus Delivery System (P940019/S058) | Boston Scientific Scimed, Inc. | 2020-06-25 |
| Artic Front Advance Pro Cardiac Cryoablation Catheter (P100010/S106) | Medtronic Cryocath, LP | 2020-06-25 |
| MiniMed 670G System (P160017/S085) | Medtronic Minimed, Inc. | 2020-06-25 |
| Restore, Itrel, Synergy, and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimu (P840001/S450) | Medtronic Neuromodulation | 2020-06-25 |
| Activia Deep Brain Stimulation Therapy System (P960009/S365) | Medtronic, Inc. | 2020-06-25 |
| Wallstent (Venous) Endoprosthesis With Unistep Plus Delivery System (P980033/S057) | Boston Scientific Corporation | 2020-06-25 |
| CERAMAX Ceramic Total Hip System (P070026/S074) | DePuy Orthopaedics, Inc. | 2020-06-24 |