| BRACAnalysis CDx® (P140020/S025) | Myriad Genetic Laboratories | 2022-11-16 |
| InterStim® Therapy System, Verify® Evaluation System (SNS Urinary) (P970004/S375) | Medtronic Neuromodulation | 2022-11-16 |
| Carpentier-Edwards PERIMOUNT Family of Pericardial Bioprostheses (P860057/S207) | Edwards Lifesciences, LLC | 2022-11-16 |
| Menicon Z (tisilfocon) Rigid Gas Permeable Contact Lens and Menicon Z Night (tisilfocon A) Contact Lenses for Overnight (P990018/S007) | Menicon Co, Ltd. | 2022-11-16 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P200015/S018) | Edwards Lifesciences, LLC | 2022-11-16 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S441) | Medtronic, Inc. | 2022-11-16 |
| Spectrum Breast Implants (P990075/S054) | Mentor Worldwide, LLC | 2022-11-16 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS RESILIA Aortic Valve, KONEC (P150048/S062) | Edwards Lifesciences, LLC | 2022-11-16 |
| Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris® (P840001/S531) | Medtronic Neuromodulation | 2022-11-16 |
| Drug Eluting Permanent Left Ventricular (LV) Pacemaker Electrode (P070008/S141) | Biotronik, Inc. | 2022-11-16 |
| Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (P140031/S140) | Edwards Lifesciences, LLC | 2022-11-16 |
| InterStim® Therapy System, Verify® Evaluation System (SNS Bowel) (P080025/S270) | Medtronic Neuromodulation | 2022-11-16 |
| Edwards INTUITY Elite Valve System (P150036/S061) | Edwards Lifesciences, LLC | 2022-11-16 |
| Edwards SAPIEN 3 Transcatheter Heart Valve System and Accessories (P140031/S149) | Edwards Lifesciences, LLC | 2022-11-16 |
| Straumann® Emdogain® (P930021/S029) | The Straumann Company | 2022-11-16 |
| PROMUS Element Plus and Promus PREMIER and Promus ELITE Everolimus-Eluting Stent System (P110010/S205) | Boston Scientific Corp | 2022-11-15 |
| REBEL Platinum Chromium Coronary Stent System Monorail and Over the Wire (P130030/S074) | Boston Scientific Corp | 2022-11-15 |
| Blazer Open-Irrigated Ablation Catheter (P150005/S073) | Boston Scientific Corp | 2022-11-15 |
| Blazer II Cardiac Ablation System and Cable (P920047/S129) | Boston Scientific Corp | 2022-11-15 |
| WLOVERINE Coronary Cutting Balloon (P950020/S128) | Boston Scientific Corp | 2022-11-15 |
| Bi-Directional Torque Wrench Model 6628 (P960040/S482) | Boston Scientific | 2022-11-15 |
| Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S137) | Boston Scientific | 2022-11-15 |
| Express® SD Renal Monorail Premounted Stent System (P060006/S104) | Boston Scientific Corp | 2022-11-15 |
| Neuroform Atlas® Stent System (P180031/S005) | Stryker Neurovascular | 2022-11-15 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S016) | Boston Scientific Corporation | 2022-11-15 |
| Therapy Ablation Catheter (4mm and 8mm), Electrophysiology Cables (16, 17, 18 and 19 Series) (P040014/S046) | Irvine Biomedical, Inc. | 2022-11-15 |
| Safire TX Ablation Catheter, Therapy Dual-8 Ablation Catheter, Safire TX, Catheter Extension Cable (P040042/S052) | Irvine Biomedical,Inc.(Ibi) | 2022-11-15 |
| Chilli Cooled RF Ablation System (P980003/S094) | Boston Scientific Corp | 2022-11-15 |
| i-FACTOR® Peptide Enhanced Bone Graft (P140019/S007) | Cerapedics, LLC | 2022-11-15 |
| Bi-Directional Torque Wrench Model 6628 (P010012/S558) | Boston Scientific Corp | 2022-11-15 |
| AtriCure Synergy Ablation System (P100046/S013) | AtriCure, Inc. | 2022-11-15 |
| Micra AV TPS, Micra TPS (P150033/S159) | Medtronic, Inc. | 2022-11-15 |
| Rotablator Rotational Atherectomy System (P900056/S203) | Boston Scientific Corp | 2022-11-15 |
| cobas® HPV (P100020/S054) | Roche Molecular Systems, Inc. | 2022-11-14 |
| AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone (N970012/S194) | Boston Scientific Corp | 2022-11-14 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S401) | Medtronic, Inc. | 2022-11-14 |
| cobas® BRAF V600 Mutation Test (P110020/S037) | Roche Molecular Systems, Inc. | 2022-11-14 |
| AMS 800 Artificial Urinary Sphincter (AUS) with and without InhibiZone (P000053/S128) | Boston Scientific Corp | 2022-11-14 |
| cobas® KRAS Mutation Test (P140023/S025) | Roche Molecular Systems, Inc. | 2022-11-14 |
| VENTANA FOLR1 (FOLR-2.1) RxDx Assay (P220006) | Ventana Medical Systems, Inc. | 2022-11-14 |
| COBAS® AmpliPrep/ COBAS® TaqMan® CMV Test (P110037/S057) | Roche Molecular Systems, Inc. | 2022-11-14 |
| MyChoice CDx® (P190014/S007) | Myriad Genetic Laboratories, Inc. | 2022-11-14 |
| OPTIMIZER Smart Mini System (P180036/S012) | Impulse Dynamics (Usa), Inc. | 2022-11-14 |
| LCS® Knee System (P830055/S300) | Depuy, Inc. | 2022-11-14 |
| cobas® EGFR Mutation Test, v2.0 (P120019/S034) | Roche | 2022-11-14 |
| Micra AV TPS and Micra TPS (P150033/S158) | Medtronic, Inc. | 2022-11-14 |
| COBAS® AmpliPrep/ COBAS® TaqMan® HBV Test, v2.0 (P050028/S086) | Roche Molecular Systems, Inc. | 2022-11-14 |
| Exablate Model 4000 Type 1.0 and 1.1 System (Exablate Neuro) (P150038/S024) | Insightec | 2022-11-11 |
| Micra AV TPS, Micra TPS (P150033/S160) | Medtronic, Inc. | 2022-11-11 |
| VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status) (P200019/S006) | Ventana Medical Systems | 2022-11-10 |
| CINtec PLUS Cytology (P190024/S008) | Ventana Medical Systems, Inc. | 2022-11-10 |
| BRACAnalysis CDx® (P140020/S024) | Myriad Genetic Laboratories | 2022-11-10 |
| PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody (P990081/S050) | Ventana Medical Systems, Inc. | 2022-11-10 |
| PATHWAY Anti-c-KIT (9.7) Primary Antibody (P020055/S028) | Ventana Medical Systems, Inc. | 2022-11-10 |
| VENTANA ALK (D5F3) CDx Assay (P140025/S020) | Ventana Medical Systems, Inc. | 2022-11-10 |
| VENTANA PD-L1 (SP263) Assay (P160046/S015) | Ventana Medical Systems, Inc. | 2022-11-10 |
| Ranger-Over-The-Wire Paclitaxel Coated Balloon Catheter (P190019/S015) | Boston Scientific Corporation | 2022-11-10 |
| INFORM HER2 Dual ISH DNA Probe Cocktail (P100027/S038) | Ventana Medical Systems, Inc. | 2022-11-10 |
| HeartMate II Left Ventricular Assist System (P060040/S088) | ABBOTT MEDICAL | 2022-11-10 |
| VENTANA PD-L1 (SP142) Assay (P160002/S019) | Ventana Medical Systems, Inc. | 2022-11-10 |
| LIFEPAK Automated External Defibrillators (AEDs) (P160026/S035) | Physio-Control, Inc. | 2022-11-10 |
| VENTANA MMR RxDx Panel (Solid Tumors with dMMR status) (P210001/S007) | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | 2022-11-10 |
| LCS® Knee System (P830055/S301) | Depuy, Inc. | 2022-11-10 |
| VENTANA HER2 Dual ISH DNA Probe Cocktail (P190031/S007) | Ventana Medical Systems, Inc. | 2022-11-10 |
| LDR Spine Mobi-C® Cervical Disc Prosthesis (P110009/S032) | Highridge Medical, LLC | 2022-11-09 |
| LDR Spine Mobi-C Cervical Disc Prosthesis (P110002/S032) | Highridge Medical, LLC | 2022-11-09 |
| AMS 700 Inflatable Penile Prosthesis, AMS 700 Inflatable Penile Prosthesis with InhibiZone (N970012/S193) | Boston Scientific Corp | 2022-11-09 |
| Tack Endovascular System (4F, 1.5-4.5mm) (P190027/S005) | Philips Image Guided Therapy Corporation (Formerly Intact) | 2022-11-09 |
| Arctic Fron Advance® Cardiac CryoAblation Catheters (P100010/S132) | Medtronic Cryocath, LP | 2022-11-09 |
| PorticoTM Transcatheter Aortic Valve Implantation System (P190023/S010) | ABBOTT MEDICAL | 2022-11-09 |
| Monovisc High Molecular Weight Hyaluronan (P090031/S015) | Anika Therapeutics, Inc. | 2022-11-08 |
| Gambro Prismaflex TPE 2000 Set (P830063/S024) | Vantive US Healthcare, LLC | 2022-11-08 |
| ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S129) | Boston Scientific | 2022-11-08 |
| VenaSeal Closure System (P140018/S035) | Medtronic Vascular, Inc. | 2022-11-08 |
| ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE (N970003/S275) | Boston Scientific Corp | 2022-11-08 |
| Orthovisc, Sodium Hyaluronic (P030019/S027) | Anika Therapeutics, Inc. | 2022-11-08 |
| VALITUDE, VALITUDE X4, VISIONIST, VISIONIST X4 (P030005/S220) | Guidant Corp. | 2022-11-08 |
| Cardiva VASCADE Family (P120016/S030) | Cardiva Medical, Inc. | 2022-11-08 |
| INNOVA Vascular Self-Expanding Stent System (P140028/S075) | Boston Scientific Corporation | 2022-11-07 |
| WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System (P130013/S055) | Boston Scientific Corp | 2022-11-07 |
| EPIC Vascular Self-Expanding Stent System (P110035/S068) | Boston Scientific Corp | 2022-11-07 |
| WOLVERINE Coronary Cutting Balloon® (P950020/S129) | Boston Scientific Corp | 2022-11-07 |
| ELUVIA Drug-Eluting Vascular Stent System (P180011/S051) | Boston Scientific Corp | 2022-11-07 |
| iStent inject W Trabecular Micro-Bypass System (P170043/S013) | Glaukos Corporation | 2022-11-07 |
| Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight Delivery System (SDS), Propel C (P100044/S050) | Intersect Ent. | 2022-11-04 |
| Monovisc High Molecular Weight Hyaluronan (P090031/S014) | Anika Therapeutics, Inc. | 2022-11-04 |
| Neuro Cochlear Implant System (NCIS) (P200021/S013) | Oticon Medical | 2022-11-04 |
| Chocolate Touch Paclitaxel Drug-Coated PTA Balloon Catheter (Chocolate Touch) (P210039) | Trireme Medical, LLC | 2022-11-04 |
| Duett Sealing Device (D-Stat Flowable) (P990037/S036) | Vascular Solutions, Inc. | 2022-11-04 |
| Micra AV TPS, Micra TPS (P150033/S155) | Medtronic, Inc. | 2022-11-04 |
| Synvisc and Synvisc-One (P940015/S050) | Sanofi Genzyme Corp. | 2022-11-04 |
| 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/S805) | Medtronic Cardiac Rhythm Disease Management | 2022-11-03 |
| Medtronic CoreValve Evolut R DCS (EnVeo R DCS), Medtronic CoreValve Evolut PRO DCS (EnVeo PRO DCS), Medtronic Evolut (P130021/S123) | Medtronic, Inc. | 2022-11-03 |
| PD-L1 IHC 22C3 pharmDx (P150013/S025) | Agilent Technologies, Inc. | 2022-11-03 |
| Micra AV TPS, Micra TPS (P150033/S156) | Medtronic, Inc. | 2022-11-03 |
| 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/S839) | Medtronic Cardiac Rhythm Disease Management | 2022-11-03 |
| Ventak® PRX Pulse Generator (P910077/S189) | Boston Scientific | 2022-11-02 |
| Ventak and Automatic Implantable Cardioverter Defibrillator (AICD) Systems (P830060/S088) | Boston Scientific | 2022-11-02 |
| AcrySof IOL Sterile UV-Absorbing Acrylic, Foldable Multipiece Posterior Chamber, Lenses, AcrySof Natural UV and Blue L (P930014/S141) | Alcon Laboratories, Inc. | 2022-11-02 |
| Exablate Model 4000 Type 1.0 and 1.1 System (Exablate Neuro) (P150038/S023) | Insightec | 2022-11-02 |