| Edwards Commander delivery system (Size 29mm) (P200015/S040) | Edwards Lifesciences, LLC | 2023-06-02 |
| WaveLight EX500 Laser System with Patient Bed Swivel 1125 (P030008/S036) | Alcon Laboratories, Inc. | 2023-06-02 |
| Mentor Saline-Filled Brest Implants, Mentor SPECTRUM® Breast Implants (P990075/S058) | Mentor Worldwide, LLC | 2023-06-02 |
| Mentor Saline-Filled Brest Implants, Mentor SPECTRUM® Breast Implants (P990075/S057) | Mentor Worldwide, LLC | 2023-06-02 |
| Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S083) | ABBOTT MEDICAL | 2023-06-02 |
| WaveLight EX500 Laser System with Patient Bed Swivel 1125 (P020050/S040) | Alcon Laboratories, Inc. | 2023-06-02 |
| HiResolution Bionic Ear System (P960058/S158) | Advanced Bionics | 2023-06-02 |
| Aptima HPV Assay (P100042/S034) | Gen-Probe Incorporated | 2023-06-02 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S058) | Medtronic Vascular | 2023-06-02 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S409) | Medtronic, Inc. | 2023-06-02 |
| Sculptra (P030050/S040) | Q-Med AB | 2023-06-02 |
| Perclose ProStyle Suture-Mediated Closure and Repair System, Perclose ProGlide Suture-Mediated Closure System (P960043/S118) | Abbott Vascular, Inc. | 2023-06-02 |
| EverFlex Self-Expanding Peripheral Stent System, EverFlex Self-Expanding Peripheral Stent with Entrust Delivery Syste (P110023/S037) | Medtronic Vascular, Inc. | 2023-06-02 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System RX and OTW, Onyx Frontier Zotarolimus-Eluting Coronary Stent S (P160043/S069) | Medtronic Vascular | 2023-06-02 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S277) | Medtronic Neuromodulation | 2023-06-02 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant II AUI Stent Graft System, Endurant IIs Stent Graf (P100021/S115) | Medtronic Vascular | 2023-06-02 |
| CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo PRO Delivery Catheter System, Evolut PRO+ Delivery Cath (P130021/S138) | Medtronic, Inc. | 2023-06-02 |
| Edwards Commander delivery system (Size 29mm) (P140031/S157) | Edwards Lifesciences, LLC | 2023-06-02 |
| Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S198) | ABBOTT MEDICAL | 2023-06-02 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S382) | Medtronic Neuromodulation | 2023-06-02 |
| Restylane® Injectable Gels (P140029/S049) | Q-Med AB | 2023-06-01 |
| Diamondback 360 Precision Coronary Orbital Atherectomy System (P130005/S036) | Cardiovascular Systems, Inc. | 2023-06-01 |
| Restylane® Injectable Gels (P040024/S137) | Q-Med AB | 2023-06-01 |
| Artic Front Advanced Cardiac Cryoablation Catheter, Artic Front Advanced PRO Cardiac Cryoablation Catheter (P100010/S138) | Medtronic Cryocath, LP | 2023-06-01 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S011) | Edwards Lifesciences, LLC | 2023-06-01 |
| Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens (P190018/S024) | Alcon Laboratories, LLC | 2023-05-31 |
| OcuCoat 1ml syringe, OcuCoat ml syrince 6 pack, OcuCoat 2ml syringe (P860047/S035) | Bausch & Lomb, Inc. | 2023-05-31 |
| LifeVest® Wearable Defibrillator (P010030/S164) | Zoll Manufacturing Corporation | 2023-05-31 |
| PASCAL Precision Transcatheter Valve Repair System (Implant System), PASCAL Precision Transcatheter Valve Repair System (P220003/S009) | Edwards Lifesciences, LLC | 2023-05-31 |
| GEM21S (P040013/S028) | Lynch Biologics, LLC | 2023-05-31 |
| LifePulse High Frequency Ventilator (P850064/S050) | Bunnell, Inc. | 2023-05-31 |
| CryoConsole (P020045/S104) | Medtronic Cryocath, LP | 2023-05-31 |
| PASCAL Precision Transcatheter Valve Repair System (Guide Sheath), PASCAL Precision Transcatheter Valve Repair System (I (P220003/S010) | Edwards Lifesciences, LLC | 2023-05-30 |
| SAPIEN 3 Pulmonic Delivery System (S3 PDS) (P200015/S039) | Edwards Lifesciences, LLC | 2023-05-30 |
| Restylane Eyelight (P040024/S138) | Q-Med AB | 2023-05-30 |
| FoundationOne CDx (P170019/S037) | Foundation Medicine, Inc. | 2023-05-26 |
| Thoraflex Hybrid (P210006/S004) | Vascutek, Ltd. | 2023-05-26 |
| CapSure Sense Lead, Vitatron Crystalline Lead (P830061/S213) | Medtronic Cardiac Rhythm Disease Management | 2023-05-26 |
| Sientra OPUS Silicone Gel Breast Implants (P070004/S018) | Tiger Aesthetics Medical, LLC | 2023-05-26 |
| CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S250) | Medtronic, Inc. | 2023-05-26 |
| VENTANA MMR RxDx Panel (P210001/S008) | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | 2023-05-26 |
| FoundationOne CDx (P170019/S044) | Foundation Medicine, Inc. | 2023-05-26 |
| Sientra OPUS Silicone Gel Breast Implants (P070004/S017) | Tiger Aesthetics Medical, LLC | 2023-05-26 |
| EPi-Sense ST RF Cable (P200002/S006) | AtriCure, Inc. | 2023-05-25 |
| Access Hybritech PSA reagent pack (P850048/S059) | Beckman Coulter, Inc. | 2023-05-25 |
| ASSURE Wearable Cardioverter Defibrillator system (ASSURE system) (P200037/S008) | Kestra Medical Technologies, Inc. | 2023-05-25 |
| Mentor Spectrum Breast Implants, Mentor Saline-Filled Breast Implants (P990075/S056) | Mentor Worldwide, LLC | 2023-05-24 |
| Mentor MemoryShape Breast Implants (P060028/S048) | Mentor Worldwide, LLC | 2023-05-24 |
| Prestige LP® Cervical Disc (P090029/S017) | Medtronic Sofamor Danek USA, Inc. | 2023-05-24 |
| FlexiTip XL-R Applicator (P050038/S041) | Davol, Inc. | 2023-05-24 |
| DuraSeal Exact Spinal Sealant (3mL), DuraSeal Exact Spinal Sealant (5mL) (P080013/S026) | Integra LifeSciences Corporation | 2023-05-24 |
| Loctite® 4206 (P200028/S017) | Medtronic, Inc. | 2023-05-24 |
| DuraSeal Dural Sealant System (P040034/S037) | Integra LifeSciences Corporation | 2023-05-24 |
| Harmony Transcatheter Pulmonic Valve System (P200046/S016) | Medtronic, Inc. | 2023-05-23 |
| CapSureFix Novus Lead (P930039/S251) | Medtronic, Inc. | 2023-05-23 |
| Endurity MRI, Assurity MRI (P140033/S080) | ABBOTT MEDICAL | 2023-05-23 |
| Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Attesta DR (P980035/S746) | Medtronic, Inc. | 2023-05-23 |
| Pulsar-18 T3 Stent System (P160025/S016) | Biotronik AG | 2023-05-23 |
| Accent, Accent MRI, Assurity, Assurity+, Endurity ,Endurity Core (P880086/S329) | ABBOTT MEDICAL | 2023-05-23 |
| TECNIS Next-Generation Presbyopia-Correcting IOL (P980040/S156) | Johnson & Johnson Surgical Vision, Inc. | 2023-05-23 |
| CPR-D-padz electrode (P160015/S015) | ZOLL Medical Corporation | 2023-05-23 |
| Sterallex 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (P160049/S021) | The Spectranetics Corp. | 2023-05-23 |
| CapSure Sense Lead (P830061/S215) | Medtronic Cardiac Rhythm Disease Management | 2023-05-23 |
| CPR-D-padz electrode (P160022/S034) | ZOLL Medical Corporation | 2023-05-23 |
| Anthem, Allure, Allure Quadra, Quadra Allure MP, Quadra Allure (MRI Conditional) (P030035/S195) | ABBOTT MEDICAL | 2023-05-23 |
| PyloPlus Urea Breath Test System (P170022/S002) | Arj Medical, Inc. | 2023-05-22 |
| Woven EndoBridge (WEB) Aneurysm Embolization System (P170032/S013) | MicroVention, Inc. | 2023-05-22 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S073) | Medtronic, Inc. | 2023-05-22 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P190008/S024) | Medtronic Vascular, Inc. | 2023-05-22 |
| LCS® Total Knee System (P830055/S307) | Depuy, Inc. | 2023-05-19 |
| Bellafill Dermal Filler (P020012/S044) | Tiger Aesthetics Medical, LLC | 2023-05-19 |
| Multifunctional Ablation Generator (MAG) (P200002/S005) | AtriCure, Inc. | 2023-05-19 |
| PerClot® Polysaccharide Hemostatic System (P210036) | Baxter Healthcare Corporation | 2023-05-19 |
| CERAMAX® Ceramic Total Hip System (P070026/S106) | DePuy Orthopaedics, Inc. | 2023-05-19 |
| 13C-Spirulina Gastric Emptying Breath Test (GEBT) (P110015/S009) | Advanced Breath Diagnostics | 2023-05-19 |
| Inspire® Upper Airway Stimulation System (P130008/S096) | Inspire Medical Systems | 2023-05-19 |
| Multifunctional Ablation Generator (MAG) (P100046/S016) | AtriCure, Inc. | 2023-05-19 |
| RxSight Light Adjustable Lens (LAL), Light Delivery Device (LDD) (P160055/S029) | Rxsight, Inc. | 2023-05-18 |
| Belotero Balance Dermal Filler, Belotero Balance(+) Lidocaine Dermal Filler (P090016/S053) | Merz North America, Inc. | 2023-05-18 |
| TactiFlex Ablation Catheter, Sensor Enabled, TactiSys Quartz Equipment, TactiSys Quartz, TactiFlex Radiofrequency C (P220013) | ABBOTT MEDICAL | 2023-05-18 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (P140031/S156) | Edwards Lifesciences, LLC | 2023-05-18 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P200015/S038) | Edwards Lifesciences, LLC | 2023-05-18 |
| Sprint Quattro Lead (P920015/S276) | Medtronic, Inc. | 2023-05-17 |
| Programming software modules for Orchestra Plus and SmartTouch programmers, Remote monitoring software (P980049/S145) | MicroPort CRM USA, Inc. | 2023-05-17 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro (P980016/S855) | Medtronic Cardiac Rhythm Disease Management | 2023-05-17 |
| ALIZEA and CELEA pacemakers, Remote monitoring software (RMS) (P950029/S133) | MicroPort CRM USA, Inc. | 2023-05-17 |
| ALIZEA and CELEA pacemakers, Remote monitoring software (RMS) (P950029/S132) | MicroPort CRM USA, Inc. | 2023-05-17 |
| 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/S821) | Medtronic Cardiac Rhythm Disease Management | 2023-05-17 |
| Programming software modules for Orchestra Plus and SmartTouch programmers, CPR4 Telemetry head accessory for SmartTouch (P980049/S144) | MicroPort CRM USA, Inc. | 2023-05-17 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S131) | Vistakon, Division of Johnson & Johnson Vision Car | 2023-05-17 |
| Precision Spinal Cord Stimulator (SCS) Systems (P030017/S360) | Boston Scientific Corp | 2023-05-17 |
| ALIZEA SR/DR and CELEA SR/DR 1.5T and 3T Full Body MRI conditional pacemakers (P950029/S127) | MicroPort CRM USA, Inc. | 2023-05-17 |
| INGEVITY+ and INGEVITY MRI Pace/Sense leads (P150012/S145) | Boston Scientific | 2023-05-17 |
| VEGA Steroid-Eluting Endocardial Leads (VEGA R45, VEGA R52, and VEGA R58) (P130010) | MicroPort CRM USA, Inc. | 2023-05-17 |
| Smartview Connect remote monitoring solution (P980049/S139) | MicroPort CRM USA, Inc. | 2023-05-17 |
| OUS HeartTone MRI Application Software (P890003/S460) | Medtronic, Inc. | 2023-05-16 |
| Guardant360 CDx (P200010/S014) | Guardant Health, Inc. | 2023-05-16 |
| cobas® HPV (P190028/S008) | Roche Molecular Systems, Inc. | 2023-05-16 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S820) | Medtronic Cardiac Rhythm Disease Management | 2023-05-16 |
| Axonics Sacral Neuromodulation System (P180046/S068) | Boston Scientific Corporation | 2023-05-16 |