| Elecsys Anti-HBe, PreciControl Anti-HBe (P190005/S002) | Roche Diagnostics | 2023-05-16 |
| GELFOAM (absorbable gelatin gel, powder from abs. gel, sponge USP), GELFOAM (compressed absorbable gelatin sponge, USP), (N18286/S041) | Pfizer, Inc. | 2023-05-16 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S854) | Medtronic Cardiac Rhythm Disease Management | 2023-05-16 |
| Axonics Sacral Neuromodulation System (P190006/S068) | Boston Scientific Corporation | 2023-05-16 |
| Precision Spinal Cord Stimulator (SCS) Systems (P030017/S362) | Boston Scientific Corp | 2023-05-15 |
| Vercise Deep Brain Stimulation (DBS) Systems (P150031/S058) | Boston Scientific Corp | 2023-05-15 |
| EUFLEXXA (P010029/S034) | Ferring Pharmaceuticals, Inc. | 2023-05-12 |
| RHA 2, RHA 3, RHA 4 (P170002/S022) | Teoxane S.A. | 2023-05-12 |
| Senza HFX iQ System (model IPG3000) (P130022/S048) | Nevro Corporation | 2023-05-12 |
| Vercise Deep Brain Stimulation (DBS) Systems (P150031/S057) | Boston Scientific Corp | 2023-05-12 |
| Precision Spinal Cord Stimulator (SCS Systems) (P030017/S361) | Boston Scientific Corp | 2023-05-12 |
| EMBLEM Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) Anneal Parameters (P110042/S182) | Boston Scientific Corporation | 2023-05-12 |
| NG3 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), NG4 CRT-Ds (P010012/S568) | Boston Scientific Corp | 2023-05-11 |
| LIAISON® XL Murex HBsAg Qual and LIAISON® XL Murex Control HBsAg (P190017/S011) | DiaSorin, Inc. | 2023-05-11 |
| Accolade CRT Pacemakers (CRT-Ps) (P030005/S229) | Guidant Corp. | 2023-05-11 |
| Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (P110042/S183) | Boston Scientific Corporation | 2023-05-11 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S008) | Edwards Lifesciences, LLC | 2023-05-11 |
| Home Monitoring System Version 3.56.0 (P000009/S103) | Biotronik, Inc. | 2023-05-11 |
| Accolade MRI Pacemakers (P150012/S142) | Boston Scientific | 2023-05-11 |
| NG3 Implantable Cardioverter Defibrillators (ICDs), NG4 ICDs (P960040/S491) | Boston Scientific | 2023-05-11 |
| Home Monitoring System Version 3.56.0 (P980023/S119) | Biotronik, Inc. | 2023-05-11 |
| Superion Indirect Decompression System (IDS) (P140004/S030) | Boston Scientific Neuromodulation | 2023-05-11 |
| CollaCote, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S089) | Integra Lifesciences Corp. | 2023-05-11 |
| Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent Fibrillar Form (P850010/S107) | Integra LifeSciences Corporation | 2023-05-11 |
| Home Monitoring System Version 3.56.0 (P950037/S247) | Biotronik, Inc. | 2023-05-11 |
| WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System (P130013/S052) | Boston Scientific Corp | 2023-05-11 |
| Tendril STS 2088TC, OptiSense Low Voltage Pacing Leads (P960013/S122) | ABBOTT MEDICAL | 2023-05-11 |
| Home Monitoring System Version 3.56.0 (P070008/S147) | Biotronik, Inc. | 2023-05-11 |
| Skinvive by Juvéderm (P110033/S059) | Allergan | 2023-05-11 |
| Home Monitoring System Version 3.56.0 (P050023/S174) | Biotronik, Inc. | 2023-05-11 |
| Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent Microfibrillar Fo (P810006/S104) | Integra LifeSciences Corporation | 2023-05-11 |
| Accolade Pacemakers (N970003/S284) | Boston Scientific Corp | 2023-05-11 |
| CollaCote, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S090) | Integra Lifesciences Corp. | 2023-05-10 |
| Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent Microfibrillar Fo (P810006/S105) | Integra LifeSciences Corporation | 2023-05-10 |
| Rotablator and ROTAPRO Rotational Atherectomy Systems (P900056/S207) | Boston Scientific Corp | 2023-05-10 |
| Prodigy, Proclaim XR, Proclaim Plus, and Externa Spinal Cord Stimulation (SCS) Systems (P010032/S191) | ABBOTT MEDICAL | 2023-05-10 |
| Eversense E3 CGM System (P160048/S024) | Senseonics, Incorporated | 2023-05-10 |
| Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent Fibrillar Form (P850010/S108) | Integra LifeSciences Corporation | 2023-05-10 |
| Navitor Transcatheter Aortic Heart Valve (P190023/S015) | ABBOTT MEDICAL | 2023-05-10 |
| Micra AV TPS, Micra TPS, Micra VR TPS (P150033/S170) | Medtronic, Inc. | 2023-05-09 |
| Micra AV H3, Micra Scalable, Micra AV TPS, Micra VR TPS (P150033/S171) | Medtronic, Inc. | 2023-05-09 |
| CT LUCIA 621P (P100016/S016) | Carl Zeiss Meditec Production, LLC | 2023-05-09 |
| Organ Care System (OCS) Liver (P200031/S003) | TransMedics, Inc. | 2023-05-09 |
| Macroplastique Implants (P040050/S013) | Uroplasty, LLC | 2023-05-09 |
| Organ Care System (OCS) Lung System (P160013/S012) | TransMedics, Inc. | 2023-05-09 |
| Organ Care System (OCS) Heart System (P180051/S003) | TransMedics, Inc. | 2023-05-09 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S044) | Medinol, Ltd. | 2023-05-09 |
| Guardant360 CDx (P200010/S013) | Guardant Health, Inc. | 2023-05-08 |
| Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter (P200039/S011) | Shockwave Medical, Inc. | 2023-05-08 |
| Restylane® Eyelight (P040024/S135) | Q-Med AB | 2023-05-08 |
| AFX2 Endovascular AAA System (P040002/S071) | Endologix, LLC | 2023-05-08 |
| Elecsys Anti-HBc II (P100031/S028) | Roche Diagnostics Corp. | 2023-05-08 |
| ESSENTIO SR, ESSENTIO DR, ESSENTIO EL DR, PROPONENT SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE SR, ACCOLADE DR, (N970003/S286) | Boston Scientific Corp | 2023-05-08 |
| Express LD Iliac Premounted Stent System (P090003/S054) | Boston Scientific Corporation | 2023-05-08 |
| VALITUDE CRT-P, VALITUDE X4 CRT-P, VISIONIST CRT-P, VISIONIST X4 CRT-P (P030005/S231) | Guidant Corp. | 2023-05-08 |
| ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, ACCOLADE MRI EL (P150012/S144) | Boston Scientific | 2023-05-08 |
| ARCHITECT HBsAg Next Qualitative and ARCHITECT HBsAg Next Confirmatory Assay (P210003/S004) | Abbott Laboratories | 2023-05-08 |
| MED-EL Cochlear Implant System (P000025/S125) | Med-El Corp. | 2023-05-05 |
| Saluda Medical Evoke SCS System (P190002/S012) | Saluda Medical Pty, Ltd. | 2023-05-05 |
| InterStim® Therapy System, Verify ® Evaluation System (P970004/S381) | Medtronic Neuromodulation | 2023-05-05 |
| Lamitrode Tripole 16 Lead 60cm Length (Model 3219), TriCentrus 16 Lead 60cm Length (Model 3292), Octrode Lead 90cm Lengt (P010032/S193) | ABBOTT MEDICAL | 2023-05-05 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY MEGATRON Everolimus-Eluting Platinum Chromi (P150003/S095) | Boston Scientific Corporation | 2023-05-05 |
| Wolverine Coronary Cutting Balloon (P950020/S138) | Boston Scientific Corp | 2023-05-05 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S276) | Medtronic Neuromodulation | 2023-05-05 |
| KARL STORZ D-Light C PDD System (P050027/S031) | KARL STORZ Endoscopy-America, Inc. | 2023-05-05 |
| - Master Restore, Itrel®, Synergy®, Intellis TM and VantaTM Spinal Cord Stimulation Systems and Pisces TM, Specify®, and (P840001/S541) | Medtronic Neuromodulation | 2023-05-04 |
| Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S197) | ABBOTT MEDICAL | 2023-05-04 |
| IN.PACT AV DCB (P190008/S023) | Medtronic Vascular, Inc. | 2023-05-04 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S380) | Medtronic Neuromodulation | 2023-05-04 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S407) | Medtronic, Inc. | 2023-05-04 |
| Spectranetics Laser Sheath (SLS ll/GlideLight) (P960042/S071) | Spectranetics (Philips) | 2023-05-04 |
| GEM21S Growth Factor Enhanced Matrix (P040013/S027) | Lynch Biologics, LLC | 2023-05-04 |
| ECLA Coronary Atherectomy Catheters (P910001/S119) | Spectranetics Corp. | 2023-05-04 |
| RADIESSE® Injectable Implant (P050037/S124) | Merz North America, Inc. | 2023-05-04 |
| iSert Preloaded IOL System: iSert 250, iSert 251, iSert 230, iSert 231 & IPure Preloaded IOL System/ Model B1PC (Clear (P080004/S046) | Hoya Surgical Optics, Inc. | 2023-05-04 |
| IN.PACT Admiral DCB (P140010/S072) | Medtronic, Inc. | 2023-05-04 |
| Micra AV TPS, Micra VR TPS (P150033/S169) | Medtronic, Inc. | 2023-05-04 |
| EDWARDS INTUITY Elite Valve System, Delivery System (P150036/S068) | Edwards Lifesciences, LLC | 2023-05-04 |
| RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, RADIESSE® Jawline (P050052/S146) | Merz North America, Inc. | 2023-05-04 |
| Proclaim Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) (P150004/S060) | ABBOTT MEDICAL | 2023-05-04 |
| Micra AV TPS, Micra VR TPS (P150033/S168) | Medtronic, Inc. | 2023-05-04 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S451) | Medtronic, Inc. | 2023-05-04 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S275) | Medtronic Neuromodulation | 2023-05-04 |
| Juvéderm Voluma XC, Juvéderm Vollure XC, Juvéderm Volbella XC, Juvéderm Volux XC (P110033/S069) | Allergan | 2023-05-03 |
| FoundationOne Liquid CDx (F1 Liquid CDx) (P190032/S005) | Foundation Medicine, Inc. | 2023-05-03 |
| Juvéderm Ultra, Ultra XC, and Ultra Plus XC, Juvéderm Ultra XC (P050047/S087) | Allergan | 2023-05-03 |
| Thermocool Smarttouch SF (P030031/S132) | Biosense Webster, Inc. | 2023-05-03 |
| MitraClip Clip Delivery System (P100009/S054) | ABBOTT MEDICAL | 2023-05-03 |
| Thermocool Smarttouch (P040036/S094) | Biosense Webster, Inc. | 2023-05-03 |
| FlexAbility Ablation Catheter, FlexAbility SE (P110016/S083) | ABBOTT MEDICAL | 2023-05-02 |
| TactiCath SE Catheter (P130026/S085) | St Jude Medical | 2023-05-02 |
| GORE TAG Thoracic Branch Endoprosthesis (TBE Device) (P210032/S007) | W. L. Gore & Associates, Inc. | 2023-05-02 |
| Amplatzer Amulet (ACP2) (P200049/S005) | ABBOTT MEDICAL | 2023-05-02 |
| CERAMAX Ceramic Total Hip System (P070026/S105) | DePuy Orthopaedics, Inc. | 2023-05-02 |
| CryoConsole (P020045/S103) | Medtronic Cryocath, LP | 2023-05-02 |
| Amplatzer Septal Occluder (ASO/ASD) (P000039/S077) | ABBOTT MEDICAL | 2023-05-02 |
| Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room (P960040/S492) | Boston Scientific | 2023-05-01 |
| Menicon Z Night (tisilfocon A) Contact Lenses for Overnight Wear, ACUVUE® Abiliti Overnight and ACUVUE® Abiliti Overni (P990018/S009) | Menicon Co, Ltd. | 2023-05-01 |
| Resolute Onyx (RX), Resolute Onyx (OTW), Resolute Onyx (RX) (2.0mm), Resolute Onyx (OTW) (2.0mm), Onyx Frontier RX Zotar (P160043/S068) | Medtronic Vascular | 2023-05-01 |
| Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room (P150012/S143) | Boston Scientific | 2023-05-01 |