| Micra TPS (P150033/S054) | Medtronic, Inc. | 2019-05-03 |
| Blazer Open-Irrigated Ablation Catheter, IntellaNav Open-Irrigated Ablation Catheter, IntellaTip MiFi Open-Irrigated Abl (P150005/S044) | Boston Scientific Corp | 2019-05-03 |
| Adapta, Versa, Sensia IPG, Attesta DR/SR MRI IPG, Relia IPG, Sphera DR/SR MRI IPG, Astra S DDR/SR MRI IPG, Astra XT DR/S (P980035/S589) | Medtronic, Inc. | 2019-05-03 |
| Blazer II XP, Blazer Prime XP, IntellaTip MiFi XP, IntellaNav XP, IntellaNav MiFi XP (P020025/S119) | Boston Scientific | 2019-05-03 |
| PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081/S039) | Ventana Medical Systems, Inc. | 2019-05-03 |
| cobas CMV (P160041/S017) | Roche Molecular Systems, Inc. | 2019-05-03 |
| Chilli II (P980003/S089) | Boston Scientific Corp | 2019-05-03 |
| Radiesse Injectable Implant (P050052/S110) | Merz North America, Inc. | 2019-05-03 |
| Amplia/Claria/Compia MRI CRT-D, Ampla/Claria/Compia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Viva Quad S/XT CRT-D, (P010031/S665) | Medtronic Cardiac Rhythm Disease Management | 2019-05-03 |
| Vercise, Vercise PC, and Vercise Gevia Deep Brain Stimulation (DBS) Systems (P150031/S019) | Boston Scientific Corp | 2019-05-03 |
| Blazer II, Blazer II HTD, Blazer Prime HTD, IntellaNav ST (P920047/S115) | Boston Scientific Corp | 2019-05-03 |
| Arctic Front Advance Cardiac CryoAblation Catheters (P100010/S091) | Medtronic Cryocath, LP | 2019-05-03 |
| cobas HBV (P150014/S024) | Roche Molecular Systems, Inc. | 2019-05-03 |
| The Pulmonx Zephyr Endobronchial Valve System (EBV) (P180002/S003) | Pulmonx Corporation | 2019-05-03 |
| INFORM HER2 Dual ISH DNA Probe Cocktail assays (P100027/S030) | Ventana Medical Systems, Inc. | 2019-05-03 |
| Elecsys free PSA Test System (P000027/S034) | Roche Diagnostics Corp. | 2019-05-03 |
| Proclaim SCS Neurostimulation System FW (P010032/S148) | ABBOTT MEDICAL | 2019-05-03 |
| Bellafill Dermal Filler (P020012/S029) | Tiger Aesthetics Medical, LLC | 2019-05-03 |
| Stellarex 0.035 OTW Drug-coated Angioplasty Ballon (P160049/S005) | The Spectranetics Corp. | 2019-05-03 |
| Ever MRI DF-1 ICD, Ever MRI ICD, Ever S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI DR/VR ICD, Primo MRI DR/VR ICD, Visia A (P980016/S705) | Medtronic Cardiac Rhythm Disease Management | 2019-05-03 |
| Percepta/Serena/Solara Bipolar CRT-P, Percepta/Serena adn Solara Quadripolar CRT-P, Consulta, Syncra and Viva CRT-P (P010015/S403) | Medtronic, Inc. | 2019-05-03 |
| cobas HPV Test (P100020/S044) | Roche Molecular Systems, Inc. | 2019-05-03 |
| iDESIGN Refractive Studio (P930016/S058) | Amo Manufacturing USA, LLC | 2019-05-03 |
| Barricaid Anular Closure Device (P160050/S002) | Intrinsic Therapeutics | 2019-05-03 |
| cobas HCV (P150015/S025) | Roche Molecular Systems, Inc. | 2019-05-03 |
| LIFEPAK CR2 Defibrillator (P170018/S003) | Physio-Control, Inc. | 2019-05-02 |
| Vercise, Vercise PC, and Vercise Gevia Deep Brain Stimulation (DBS) Systems (P150031/S018) | Boston Scientific Corp | 2019-05-02 |
| VICI VENOUS STENT System (P180013) | Boston Scientific Corporation | 2019-05-02 |
| TMR Holmium Laser System (P970029/S039) | Cryolife, Inc. | 2019-05-02 |
| ELUVIA Drug-Eluting Vascular Stent System (P180011/S004) | Boston Scientific Corp | 2019-05-02 |
| LAP-BAND Adjustable Gastric Banding System (P000008/S045) | Medtimo, Inc. | 2019-05-02 |
| ROTAPRO Rotational Atherectomy System Console (P900056/S176) | Boston Scientific Corp | 2019-05-02 |
| Oxford Partial Knee System (P010014/S086) | Biomet Manufacturing Corp | 2019-05-02 |
| Adapta, Versa, Sensia, Advisa DR, Advisa DR MRI, Advisa SR MRI, Astra S DR MRI, Astra S SR MRI, Astra XT DR MRI, Astra X (P980035/S586) | Medtronic, Inc. | 2019-05-01 |
| Implantable System for Remodulin (P140032/S031) | Medtronic, Inc. | 2019-05-01 |
| MiniMed 670G System (P160017/S060) | Medtronic Minimed, Inc. | 2019-05-01 |
| Guardian Connect system (P160007/S017) | Medtronic Minimed | 2019-05-01 |
| MiniMed 630G System (P150001/S063) | Medtronic Minimed | 2019-05-01 |
| Arctic Front, Front Advance Cardiac Cryoablation, Freezor MAX & CryoConsoleSystem (P100010/S086) | Medtronic Cryocath, LP | 2019-05-01 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S329) | Medtronic, Inc. | 2019-05-01 |
| Minimed 630G System with SmartGuard (P150001/S064) | Medtronic Minimed | 2019-05-01 |
| Cordis EXOSEAL Vascular Closure Device (P100013/S019) | Cordis US Corporation | 2019-05-01 |
| InterStim Therapy System, Verify Evaluation System (SNS Bowel) (P080025/S181) | Medtronic Neuromodulation | 2019-05-01 |
| Activa Deep Brain Stimulation Therapy System (P960009/S345) | Medtronic, Inc. | 2019-05-01 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S286) | Medtronic Neuromodulation | 2019-05-01 |
| Consulta, Percepta Bipolar, Percepta Quadripolar, Serena Bipolar, Serena Quadripolar, Solara Bipolar, Solara Quadripolar (P010015/S402) | Medtronic, Inc. | 2019-05-01 |
| HV Splitter/Adaptor kit, Spriint Quattro Lead (P920015/S228) | Medtronic, Inc. | 2019-05-01 |
| Amplia MRI, Amplia MRI Quad, Brava, Brava Quad, Claria MRI, Claria MRI Quad, Consulta, Protecta, Protecta XT, Viva Quad (P010031/S664) | Medtronic Cardiac Rhythm Disease Management | 2019-05-01 |
| Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify and Vectris Spinal Cord Stimulation Lead (P840001/S428) | Medtronic Neuromodulation | 2019-05-01 |
| BIOLON (P960011/S031) | Altacor , Ltd. | 2019-05-01 |
| MiniMed 670G System (P160017/S059) | Medtronic Minimed, Inc. | 2019-05-01 |
| HeartMate 3 (HM3) Left Ventricular Assist System (LVAS) (P160054/S018) | ABBOTT MEDICAL | 2019-05-01 |
| Evera MRI DF-1, Evera MRI, Evera S DR, Evera S VR, Evera XT DR, Evera XT VR, Mirro MRI DR, Mirro MRI VR, Primo MRI DR, P (P980016/S704) | Medtronic Cardiac Rhythm Disease Management | 2019-05-01 |
| Cordis S.M.A.R.T. CONTROL / S.M.A.R.T. Vascular (P120002/S015) | Cordis US Corporation | 2019-04-30 |
| LCS Total Knee System (P830055/S228) | Depuy, Inc. | 2019-04-30 |
| Cordis S.M.A.R.T. CONTROL Nitinol Stent System (P020036/S040) | Cordis US Corporation | 2019-04-30 |
| ENROUTE TRANSCAROTID STENT SYSTEM (P140026/S012) | Boston Scientific Corporation | 2019-04-30 |
| RingJect (P030023/S006) | Ophtec BV | 2019-04-30 |
| Cordis PRECISE Nitinol Stent System (P030047/S038) | Cordis US Corporation | 2019-04-30 |
| Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S430) | Medtronic Neuromodulation | 2019-04-29 |
| ThermoCool SmartTouch SF Catheter (P040036/S065) | Biosense Webster, Inc. | 2019-04-29 |
| QuantiFERON- TB Gold Test and QuantiFERON- TB Gold Plus Test (P010033/S044) | Qiagen | 2019-04-29 |
| Activa Deep Brain Stimulation Therapy System (P960009/S346) | Medtronic, Inc. | 2019-04-29 |
| Corox (ProMRI0 OTW,75,85,S75,L75,LB85 BP; Sentus (ProMRI) OTW,75,85,S75,S85,L75,L85,QP S75S85,S95,l75,l85,L95,S75/49,S75 (P070008/S099) | Biotronik, Inc. | 2019-04-29 |
| Plexa ProMRI DF- S DX 65/15/17; IIivia 7 DR-T; Inrica 5 DTR-T (P980023/S087) | Biotronik, Inc. | 2019-04-29 |
| ThermoCool SmartTouch Catheter (P030031/S095) | Biosense Webster, Inc. | 2019-04-29 |
| Quantiferon - TB Gold Plus Test (P010033/S045) | Qiagen | 2019-04-29 |
| SmartAblate Irrigation Pump, nGEN Pump Devices (P990071/S042) | Biosense Webster, Inc. | 2019-04-29 |
| Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S429) | Medtronic Neuromodulation | 2019-04-29 |
| IIivia, 7 HF-T,QP; Intica 7,5 HF-T,QP (P050023/S126) | Biotronik, Inc. | 2019-04-29 |
| Setrox S 53; Safio S 53; Dextrus 4136;TILDA R53;Solia S 45/53/60, JT 45/53; Siello S53/60/45/53/60/,JT 45/53; (P950037/S198) | Biotronik, Inc. | 2019-04-29 |
| Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD) (P810031/S065) | Johnson & Johnson Surgical Vision, Inc. | 2019-04-29 |
| APTIMA HPV 16 18/45 Genotype Assay (P120007/S020) | Gen-Probe Incorporated | 2019-04-28 |
| APTIMA HPV Assay (P100042/S022) | Gen-Probe Incorporated | 2019-04-28 |
| APTIMA HCV Quant Dx Assay (P160023/S011) | Hologic, Inc. | 2019-04-28 |
| Aptima HBV Quant Assay (P170025/S010) | Hologic, Inc. | 2019-04-28 |
| APTIMA HCV Quant Dx Assay (P160023/S012) | Hologic, Inc. | 2019-04-26 |
| Helistat and Helitene Absorbable Collagen Hemostatic Agent (P850010/S086) | Integra LifeSciences Corporation | 2019-04-26 |
| APTIMA HPV 16 18/45 Genotype Assay (P120007/S021) | Gen-Probe Incorporated | 2019-04-26 |
| Resolute Onyx Over-the-Wire (OTW) Zotarolimus Eluting Coronary Stent System (P160043/S023) | Medtronic Vascular | 2019-04-26 |
| Straumann Emdogain (P930021/S022) | The Straumann Company | 2019-04-26 |
| Obalon Touch Dispenser (P160001/S036) | Medtimo, Inc. | 2019-04-26 |
| Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Hemostatic Agent - Microfibrillar Form (P810006/S086) | Integra LifeSciences Corporation | 2019-04-26 |
| Aptima HBV Quant Assay (P170025/S011) | Hologic, Inc. | 2019-04-26 |
| Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat (P900033/S078) | Integra Lifesciences Corp. | 2019-04-26 |
| XPS with Steen Solution Perfusate (P180014) | Xvivo Perfusion, Inc. | 2019-04-26 |
| CollaCote, CollaTape, and CollaPlug Absorbable Collagen Wound Dressings for Dental Surgergy (P840062/S073) | Integra Lifesciences Corp. | 2019-04-26 |
| Prestige LP Cervical Disc (P090029/S011) | Medtronic Sofamor Danek USA, Inc. | 2019-04-26 |
| APTIMA HPV ASSAY (P100042/S023) | Gen-Probe Incorporated | 2019-04-26 |
| NeuroPace RNS System (P100026/S067) | NeuroPace, Inc. | 2019-04-26 |
| Ceramax Ceramic Total Hip System (P070026/S060) | DePuy Orthopaedics, Inc. | 2019-04-26 |
| APTIMA HCV RNA Qualitative Assay (P020011/S013) | Gen-Probe | 2019-04-26 |
| Exablate 4000 System (P150038/S011) | Insightec | 2019-04-25 |
| cobas HCV Test (P150015/S024) | Roche Molecular Systems, Inc. | 2019-04-25 |
| PRO-Kinetic Energy Coronary Stent System (P160003/S006) | Biotronik AG | 2019-04-25 |
| Elecsys total PSA (P990056/S035) | Roche Diagnostics Corp. | 2019-04-24 |
| Elecsys Anti-HBc II (P100032/S020) | Roche Diagnostics Corp. | 2019-04-24 |
| Lotrafilcon A Soft Contact Lenses; Lotrafilcon B Soft Contact Lenses (P010019/S069) | Alcon Laboratories, Inc. | 2019-04-24 |
| Elecsys Anti-HBc II (P100031/S026) | Roche Diagnostics Corp. | 2019-04-24 |
| Elecsys Anti-HBs (P010054/S040) | Roche Diagnostics Corp. | 2019-04-24 |