| Neuro Cochlear Implant System (P200021/S004) | Oticon Medical | 2021-09-10 |
| Inspire II Upper Airway Stimulator (P130008/S073) | Inspire Medical Systems | 2021-09-10 |
| SURGICEL ORIGINAL Absorbable Hemostat, SURGICEL Nu-Knit Absorbable Hemostat, SURGICEL Fibrillar Absorbable Hemostat, (N12159/S083) | ETHICON, Inc. | 2021-09-10 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S042) | ETHICON, Inc. | 2021-09-10 |
| Endurant II Stent Graft System, Endurant IIs Stent Graft System (P100021/S095) | Medtronic Vascular | 2021-09-10 |
| Freezor, Freezor Xtra and Freezor MAX Cardiac Cryoablation Catheter, Electrical Umbilical and Coax Umbilical cable (P020045/S097) | Medtronic Cryocath, LP | 2021-09-10 |
| Arctic Front Advance, Arctic Front Advance Pro Cardiac Cryoablation Catheter and Manual Retraction Kit (P100010/S117) | Medtronic Cryocath, LP | 2021-09-10 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S045) | Boston Scientific Corp | 2021-09-10 |
| Juvéderm® Volbella XC (P110033/S062) | Allergan | 2021-09-10 |
| Defibtech Automated External Defibrillator (AED) Systems (P160032/S010) | Defibtech, LLC | 2021-09-10 |
| CERAMAX® Ceramic Total Hip System (P070026/S085) | DePuy Orthopaedics, Inc. | 2021-09-10 |
| Carbomedics Prosthetic Heart Valve (CPHV) (P900060/S063) | Corcym S.r.l. | 2021-09-09 |
| SenSight Directional Lead Kit (P960009/S407) | Medtronic, Inc. | 2021-09-09 |
| Abbott ARCHITECT AUSAB Reagent (100 Test), Abbott ARCHITECT AUSAB Reagent (500 Test), Abbott ARCHITECT AUSAB Reagent, Al (P050051/S042) | Abbott Laboratories, Inc. | 2021-09-09 |
| WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S046) | Boston Scientific Corp | 2021-09-09 |
| Carpentier-Edwards PERIMOUNT Theon RSR Pericardial Aortic Bioprosthesis with ThermaFix® tissue process, Carpentier-Edwar (P860057/S203) | Edwards Lifesciences, LLC | 2021-09-08 |
| Neuro Cochlear Implant System (P200021/S003) | Oticon Medical | 2021-09-08 |
| Edwards INSPIRIS RESILIA Aortic Valve (P150048/S057) | Edwards Lifesciences, LLC | 2021-09-08 |
| 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/S690) | Medtronic, Inc. | 2021-09-08 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S482) | Medtronic, Inc. | 2021-09-08 |
| AMS 700 Inflatable Penile Prosthesis with and without InhibiZone (N970012/S189) | Boston Scientific Corp | 2021-09-08 |
| Tula System (P190016/S003) | Tusker Medical, Inc. | 2021-09-08 |
| Edwards INTUITY Elite Valve (P150036/S056) | Edwards Lifesciences, LLC | 2021-09-08 |
| INTEGRA Dermal Regeneration Template and Integra Meshed Dermal Regeneration Template (P900033/S094) | Integra Lifesciences Corp. | 2021-09-07 |
| CollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S080) | Integra Lifesciences Corp. | 2021-09-07 |
| Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent Microfibrillar Form (P810006/S095) | Integra LifeSciences Corporation | 2021-09-07 |
| Tack Endovascular System (6F) (P180034/S005) | Philips Image Guided Therapy Corporation | 2021-09-07 |
| THERMOCOOL SMARTTOUCH® Uni-Directional Navigation Catheter, THERMOCOOL SMARTTOUCH® Bi-Directional Navigation Catheter, T (P030031/S123) | Biosense Webster, Inc. | 2021-09-07 |
| IntellaNav Open Irrigated Ablation Catheters, IntellaNav MiFi Open-Irrigated Ablation Catheters (P150005/S067) | Boston Scientific Corp | 2021-09-07 |
| IntellaNav MiFi XP, IntellaNav XP (P020025/S133) | Boston Scientific | 2021-09-07 |
| Helistat Absorbable Collagen Hemostatic Agent and Helitene Absorbable Collagen Hemostatic Agent Fibrillar Form (P850010/S095) | Integra LifeSciences Corporation | 2021-09-07 |
| Perclose ProStyle Suture-Mediated Closure and Repair System (P960043/S113) | Abbott Vascular, Inc. | 2021-09-07 |
| IntellaNav ST (P920047/S125) | Boston Scientific Corp | 2021-09-07 |
| Lutonix 035 Drug Coated Balloon PTA Catheter (P170003/S022) | Lutonix | 2021-09-07 |
| THERMOCOOL SMARTTOUCH® Uni-Directional Navigation Catheter, THERMOCOOL SMARTTOUCH® Bi-Directional Navigation Catheter (P040036/S085) | Biosense Webster, Inc. | 2021-09-07 |
| Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (P140031/S132) | Edwards Lifesciences, LLC | 2021-09-03 |
| VALITUDE, VALITUDE X4, VISIONIST, VISIONIST X4 (P030005/S210) | Guidant Corp. | 2021-09-03 |
| Sentus QP leads (P070008/S129) | Biotronik, Inc. | 2021-09-03 |
| MED-EL Cochlear Implant System (P000025/S122) | Med-El Corp. | 2021-09-03 |
| Organ Care System (OCS) Heart System (P180051) | TransMedics, Inc. | 2021-09-03 |
| Monovisc High Molecular Weight Hyaluronan (P090031/S010) | Anika Therapeutics, Inc. | 2021-09-03 |
| ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE (N970003/S265) | Boston Scientific Corp | 2021-09-03 |
| Synvisc, Synvisc-One (P940015/S049) | Sanofi Genzyme Corp. | 2021-09-03 |
| ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S112) | Boston Scientific | 2021-09-03 |
| Spectranetics Laser Sheath (SLS) (P910001/S112) | Spectranetics Corp. | 2021-09-02 |
| GELSYN-3 (P110005/S009) | Ibsa Institut Biochimique SA | 2021-09-02 |
| Glidelight Laser Sheath (P960042/S070) | Spectranetics (Philips) | 2021-09-02 |
| Radiesse (+) Injectable Implant (P050052/S129) | Merz North America, Inc. | 2021-09-01 |
| Master Restore, Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, Vectris Spinal C (P840001/S498) | Medtronic Neuromodulation | 2021-09-01 |
| Cerene Cryotherapy Device (P180032/S009) | Channel Medsystems, Inc. | 2021-09-01 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S053) | Abbott Diabetes Care, Inc. | 2021-09-01 |
| Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF, (P030054/S395) | ABBOTT MEDICAL | 2021-09-01 |
| InterStim Therapy System, Verify Evaluation System (P080025/S233) | Medtronic Neuromodulation | 2021-09-01 |
| 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, Ev (P980016/S790) | Medtronic Cardiac Rhythm Disease Management | 2021-09-01 |
| Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S406) | Medtronic, Inc. | 2021-09-01 |
| 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 M (P010031/S755) | Medtronic Cardiac Rhythm Disease Management | 2021-09-01 |
| FreeStyle Libre 14-Day Flash Glucose Monitoring System (P160030/S047) | Abbott Diabetes Care, Inc. | 2021-09-01 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis (P160021/S032) | W. L. Gore & Associates, Inc. | 2021-09-01 |
| InterStim Therapy System, Verify Evaluation System (P970004/S338) | Medtronic Neuromodulation | 2021-09-01 |
| Avant VR, Neutrino NxT VR, Gallant VR, Entrant VR, Avant DR, Neutrino NxT DR, Gallant DR, Entrant DR (P910023/S440) | ABBOTT MEDICAL | 2021-09-01 |
| LifeVest Wearable Defibrillator (P010030/S150) | Zoll Manufacturing Corporation | 2021-09-01 |
| Spiration Valve System (P180007/S008) | Gyrus Acmi, Inc. | 2021-09-01 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S041) | ETHICON, Inc. | 2021-08-31 |
| EXOGEN Ultrasound Bone Healing System (P900009/S047) | Bioventus, LLC | 2021-08-31 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System, Resolute Onyx Zotarolimus-Eluting Coronary Stent System (2.0mm) (P160043/S054) | Medtronic Vascular | 2021-08-31 |
| EDWARDS INTUITY Elite Aortic Valve (P150036/S055) | Edwards Lifesciences, LLC | 2021-08-31 |
| SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve and Accessories (P140031/S133) | Edwards Lifesciences, LLC | 2021-08-31 |
| INOUE-BALLOON Catheter (P910054/S008) | Toray Industries (America), Inc. | 2021-08-31 |
| SAPIEN 3 Transcatheter Heart Valve and Accesssories (P200015/S012) | Edwards Lifesciences, LLC | 2021-08-31 |
| Physician Programmer Cable (P130008/S068) | Inspire Medical Systems | 2021-08-31 |
| Implantable System for Remodulin (P140032/S074) | Medtronic, Inc. | 2021-08-31 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent System, Resolute Integrity Zotarolimus-Eluting Coronary Stent Syst (P110013/S114) | Medtronic Vascular | 2021-08-31 |
| SURGICEL ORIGINAL Absorbable Hemostat, SURGICEL Nu-Knit Absorbable Hemostat, SURGICEL Fibrillar Absorbable Hemostat, SUR (N12159/S082) | ETHICON, Inc. | 2021-08-31 |
| iStent inject W Trabecular Micro-Bypass System (P170043/S009) | Glaukos Corporation | 2021-08-31 |
| SynchroMed Infusion System and Ascenda Intrathecal Catheters (P860004/S368) | Medtronic, Inc. | 2021-08-30 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S084) | Hologic, Inc. | 2021-08-30 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary) (P970004/S329) | Medtronic Neuromodulation | 2021-08-30 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel) (P080025/S224) | Medtronic Neuromodulation | 2021-08-30 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S484) | Medtronic Neuromodulation | 2021-08-30 |
| Activa Deep Brain Stimulation Therapy System (P960009/S396) | Medtronic, Inc. | 2021-08-30 |
| Cerene Cryotherapy Device (P180032/S006) | Channel Medsystems, Inc. | 2021-08-27 |
| Amvisc Ophthalmic Viscosurgical Device, Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (P810025/S043) | Bausch & Lomb, Inc. | 2021-08-27 |
| PureVision (balafilcon A) Contact Lens (P980006/S032) | Bausch & Lomb, Inc. | 2021-08-27 |
| RADIESSE Injectable Implant (P050037/S110) | Merz North America, Inc. | 2021-08-27 |
| Lotrafilcon A and B Soft Contact Lenses for Daily and Extended Wear (P010019/S078) | Alcon Laboratories, Inc. | 2021-08-27 |
| Vivistim® System (P210007) | Mobia Medical, Inc. | 2021-08-27 |
| RADIESSE Injectable Implant, RADIESSE Hands, and RADIESSE (+) Lidocaine Dermal Filler (P050052/S128) | Merz North America, Inc. | 2021-08-27 |
| Ultra (samfilcon A) Contact Lens (P170035/S013) | Bausch and Lomb, Inc., | 2021-08-27 |
| LeukoStrat CDx FLT3 Mutation Assay (P160040/S007) | Invivoscribe Technologies, Inc. | 2021-08-26 |
| Superion Indirect Decompression System (IDS) (P140004/S025) | Boston Scientific Neuromodulation | 2021-08-26 |
| WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System (FLX) (P130013/S045) | Boston Scientific Corp | 2021-08-25 |
| Oncomine Dx Target Test (P160045/S028) | Life Technologies Corporation | 2021-08-25 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S489) | Medtronic Neuromodulation | 2021-08-25 |
| Atellica® IM Alpha Fetoprotein (AFP) Assay (P930036/S017) | Siemens Healthcare Diagnostics, Inc. | 2021-08-25 |
| SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. (P990004/S049) | Ferrosan Meidcal Devices A/S | 2021-08-25 |
| Restylane Injectable Gel (P040024/S126) | Q-Med AB | 2021-08-25 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S236) | Medtronic Neuromodulation | 2021-08-24 |
| BD Onclarity HPV Assay/BD COR System (P160037/S005) | Becton, Dickinson and Company | 2021-08-24 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S341) | Medtronic Neuromodulation | 2021-08-24 |
| VISTAKON® (senofilcon A) Brand Contact Lenses (P040045/S122) | Vistakon, Division of Johnson & Johnson Vision Car | 2021-08-23 |