| Bellafill Dermal Filler (P020012/S040) | Tiger Aesthetics Medical, LLC | 2022-01-21 |
| 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/S803) | Medtronic Cardiac Rhythm Disease Management | 2022-01-21 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S043) | ETHICON, Inc. | 2022-01-21 |
| Restore, Itrel, Synergy, Intellis, and Vanta Spinal Cord Stimulation Systems, Pisces, Specify and Vectris Spinal Cord St (P840001/S469) | Medtronic Neuromodulation | 2022-01-21 |
| LIAISON® QuantiFERON-TB Gold Plus and LIAISON® Control QuantiFERON-TB Gold Plus (P180047/S011) | DiaSorin, Inc. | 2022-01-21 |
| CERAMAX Ceramic Total Hip System (P070026/S089) | DePuy Orthopaedics, Inc. | 2022-01-21 |
| 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/S769) | Medtronic Cardiac Rhythm Disease Management | 2022-01-21 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S489) | Medtronic, Inc. | 2022-01-21 |
| LIAISON® XL MUREX Anti-HBc and LIAISON® XL MUREX Control Anti-HBC (P180038/S006) | DiaSorin, Inc. | 2022-01-21 |
| Zenith Fenestrated AAA Endovascular Graft (P020018/S060) | Cook, Inc. | 2022-01-20 |
| LCS Total Knee System (P830055/S279) | Depuy, Inc. | 2022-01-20 |
| Medtronic Open Pivot Mechanical Valve (OPHV), Medtronic Open Pivot Aortic Valved Graft (AVG) (P990046/S060) | Medtronic Ats Medical, Inc. | 2022-01-20 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S049) | ETHICON, Inc. | 2022-01-20 |
| SURGICEL ORIGINAL Absorbable Hemostat, SURGICEL Nu-Knit Absorbable Hemostat, SURGICEL Fibrillar Absorbable Hemostat, (N12159/S090) | ETHICON, Inc. | 2022-01-20 |
| Dexcom G5 Mobile Continuous Glucose Monitoring System (P120005/S088) | Dexcom, Inc. | 2022-01-20 |
| Arctic Front Advance, Arctic Front Advance Pro TM Cardiac Cryoablation Catheter (P100010/S124) | Medtronic Cryocath, LP | 2022-01-20 |
| Roche Cobas HBV (P150014/S042) | Roche Molecular Systems, Inc. | 2022-01-19 |
| Cobas HPV (P190028/S006) | Roche Molecular Systems, Inc. | 2022-01-19 |
| enVista® Hydrophobic Acrylic Intraocular Lens (IOL) (P910056/S049) | Bausch & Lomb, Inc. | 2022-01-19 |
| LCS® Total Knee System (P830055/S278) | Depuy, Inc. | 2022-01-19 |
| Akreos® Posterior Chamber Intraocular Lens (IOL) (P060022/S029) | Bausch & Lomb, Inc. | 2022-01-19 |
| Crystalens Accommodating Posterior Chamber & Trulign Toric Intraocular Lenses (IOL) (P030002/S040) | Bausch & Lomb, Inc. | 2022-01-19 |
| Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S416) | Medtronic, Inc. | 2022-01-19 |
| SURGIFOAM® Absorbable Gelatin Sponge, SURGIFLO® Hemostatic Matrix, SURGIFOAM® Absorbable Gelatin Powder, SURGIFOAM® Abso (P990004/S052) | Ferrosan Meidcal Devices A/S | 2022-01-19 |
| Freestyle Libre 14 day Flash Glucose Monitoring System (P160030/S048) | Abbott Diabetes Care, Inc. | 2022-01-19 |
| SURGICEL SNoW Absorbable Hemostat (N12159/S091) | ETHICON, Inc. | 2022-01-19 |
| Optilume Urethral Drug Coated Balloon (P210020/S001) | Urotronic, Inc. | 2022-01-19 |
| Cobas CMV (P160041/S034) | Roche Molecular Systems, Inc. | 2022-01-19 |
| Sofport® Advanced Optics Posterior Chamber Intraocular Lens (IOL) (P910061/S027) | Bausch & Lomb | 2022-01-19 |
| FoundationOne CDx (F1CDx) (P170019/S030) | Foundation Medicine, Inc. | 2022-01-19 |
| Master Restore, ltrel, Synergy, lntellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spin (P840001/S507) | Medtronic Neuromodulation | 2022-01-19 |
| Micra AV TPS, Micra TPS (P150033/S130) | Medtronic, Inc. | 2022-01-18 |
| Senza Spinal Cord Stimulation (SCS) System (P130022/S042) | Nevro Corporation | 2022-01-18 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S010) | Boston Scientific Corporation | 2022-01-18 |
| NeuroPace® RNS® System (P100026/S088) | NeuroPace, Inc. | 2022-01-18 |
| Astra S DR/SR MRI IPG, Astra XT DR/SR MRI IPG, Azure S DR/SR MRI IPG and Azure XT DR/SR MRI IPG (P980035/S700) | Medtronic, Inc. | 2022-01-18 |
| Axonics Sacral Neuromodulation System (P190006/S047) | Boston Scientific Corporation | 2022-01-14 |
| LIPOSORBER LA-15 System (P910018/S032) | Kaneka Pharma America Corp. | 2022-01-14 |
| Neuro Cochlear Implant System (P200021/S010) | Oticon Medical | 2022-01-14 |
| HiResolution Bionic Ear System (P960058/S154) | Advanced Bionics | 2022-01-14 |
| WEB Aneurysm Embolization System (P170032/S011) | MicroVention, Inc. | 2022-01-14 |
| Axonics Sacral Neuromodulation System (P180046/S047) | Boston Scientific Corporation | 2022-01-14 |
| Bausch+ Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophillic) Contact Lenses (P170035/S015) | Bausch and Lomb, Inc., | 2022-01-13 |
| InterStim® Therapy System (P080025/S246) | Medtronic Neuromodulation | 2022-01-13 |
| Amplatzer Duct Occluder, Amplatzer Duct Occluder II (P020024/S066) | ABBOTT MEDICAL | 2022-01-13 |
| Avant VR; Neutrino NxT VR; Gallant VR; Neutrino NxT VR; Entrant VR; Avant DR; Neutrino NxT DR; Gallant DR; Neutrino NxT (P910023/S442) | ABBOTT MEDICAL | 2022-01-13 |
| Amplatzer Septal Occluder and Amplatzer Cribriform Occluder (P000039/S076) | ABBOTT MEDICAL | 2022-01-13 |
| Master InterStim® Therapy System (P970004/S351) | Medtronic Neuromodulation | 2022-01-13 |
| Resolute Onyx OTW Zotarolimus-Eluting Coronary Stent Systems (P160043/S057) | Medtronic Vascular | 2022-01-13 |
| Avant HF; Neutrino NxT HF; Gallant HF; Neutrino NxT HF; Entrant HF; (P030054/S397) | ABBOTT MEDICAL | 2022-01-13 |
| Amplatzer Muscular VSD Occluder (P040040/S045) | ABBOTT MEDICAL | 2022-01-13 |
| Bausch+ Lomb Pure Vision® (balafilcon A) Visibility Tinted Soft Contact Lenses (P980006/S033) | Bausch & Lomb, Inc. | 2022-01-13 |
| Amplatzer PFO Occluder (P120021/S022) | ABBOTT MEDICAL | 2022-01-13 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S044) | ABBOTT MEDICAL | 2022-01-12 |
| HeartMate II Left Ventricular Assist System (LVAS) (P060040/S082) | ABBOTT MEDICAL | 2022-01-12 |
| AIR OPTIX NIGHT & DAY AQUA, AIR OPTIX AQUA, AIR OPTIX AQUA MULTIFOCAL, AIR OPTIX Plus HYDRAGLYDE, AIR OPTIX Plus HYDRAGL (P010019/S081) | Alcon Laboratories, Inc. | 2022-01-12 |
| 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/S694) | Medtronic, Inc. | 2022-01-12 |
| Prometra Programmable Infusion Pump System (P080012/S068) | Infusyn Therapeutics, LLC | 2022-01-12 |
| EverFlex Self-Expanding Peripheral Stent System, EverFlex Self-Expanding Peripheral Stent with Entrust Delivery Syste (P110023/S033) | Medtronic Vascular, Inc. | 2022-01-11 |
| Minerva® Endometrial Ablation System (P140013/S013) | Axora Medical, Inc. | 2022-01-11 |
| Elecsys Anti-HBs (P010054/S042) | Roche Diagnostics Corp. | 2022-01-11 |
| Elecsys Anti-HBc IgM Immunoassays (P110022/S028) | Roche Diagnostics Corp. | 2022-01-11 |
| EPi-Sense Guided Coagulation System (P200002/S001) | AtriCure, Inc. | 2022-01-10 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S488) | Medtronic, Inc. | 2022-01-10 |
| Nucleus 24 Cochlear Implant System (P970051/S205) | Cochlear Americas | 2022-01-10 |
| remede® System (P160039/S007) | Respicardia | 2022-01-10 |
| 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/S699) | Medtronic, Inc. | 2022-01-10 |
| Assurity MRI, Endurity MRI family of Pacemakers (P140033/S071) | ABBOTT MEDICAL | 2022-01-07 |
| Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs (P910023/S441) | ABBOTT MEDICAL | 2022-01-07 |
| i-FACTOR Peptide Enhanced Bone Graft (P140019/S005) | Cerapedics, LLC | 2022-01-07 |
| Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ (P030054/S396) | ABBOTT MEDICAL | 2022-01-07 |
| Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S188) | ABBOTT MEDICAL | 2022-01-07 |
| Assurity, Assurity+, Endurity, Accent family of Pacemakers. (P880086/S322) | ABBOTT MEDICAL | 2022-01-07 |
| LINX Reflux Management System (P100049/S030) | Torax Medical | 2022-01-07 |
| Microny family of Pacemakers (P970013/S089) | ABBOTT MEDICAL | 2022-01-07 |
| HeartMate 3 Left Ventricular Assist System (P160054/S043) | ABBOTT MEDICAL | 2022-01-07 |
| LINX Reflux Management System (P100049/S031) | Torax Medical | 2022-01-07 |
| LINX Reflux Management System (P100049/S032) | Torax Medical | 2022-01-07 |
| Exogen (P900009/S048) | Bioventus, LLC | 2022-01-07 |
| Filshie Clip (Mark VI) System (P920046/S012) | Femcare , Ltd. | 2022-01-06 |
| Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S137) | CooperVision, Inc. | 2022-01-06 |
| ADVIA Centaur Anti-HBe2 (AHBe2) Assay (P200017/S001) | Siemens Healthcare Diagnostics, Inc. | 2022-01-06 |
| NexGen® LPS-Flex / LPS-Mobile Bearing Knee (P060037/S076) | Zimmer, Inc. | 2022-01-05 |
| 9600CR Crimper (P140031/S138) | Edwards Lifesciences, LLC | 2022-01-04 |
| Axonics Sacral Neuromodulation System (P180046/S041) | Boston Scientific Corporation | 2022-01-04 |
| Shockwave C2 Intravascular (IVL) Catheter, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) (P200039/S004) | Shockwave Medical, Inc. | 2022-01-04 |
| NovaSure Impedance Controlled Endometrial Ablation System (P010013/S085) | Hologic, Inc. | 2022-01-04 |
| Raindrop® Near Vision Inlay (P150034/S009) | Rvo 2.0, Inc. (D.B.A. Optics Medical) | 2022-01-04 |
| 9600CR Crimper (P200015/S016) | Edwards Lifesciences, LLC | 2022-01-04 |
| Pearle Vision Monthly Balance (P080011/S130) | CooperVision, Inc. | 2022-01-04 |
| Axonics Sacral Neuromodulation System (P190006/S041) | Boston Scientific Corporation | 2022-01-04 |
| Endurant Stent Graft System, Endurant II Stent Graft System (P100021/S099) | Medtronic Vascular | 2022-01-03 |