| Obalon Balloon Kit, Obalon Navigation Balloon Kit, and Obalon Touch Balloon Kit (P160001/S041) | Medtimo, Inc. | 2019-07-03 |
| Algovita Spinal Cord Stimulation System (P130028/S024) | Nuvectra Corporation | 2019-07-03 |
| Activa Deep Brain Stimulation Therapy System (P960009/S333) | Medtronic, Inc. | 2019-07-03 |
| Impella CP with SmartAssist (P140003/S055) | Abiomed, Inc. | 2019-07-03 |
| Juvederm Injectable Gel Implants (P050047/S069) | Allergan | 2019-07-03 |
| enVista One Piece Hydrophobic Acrylic Intraocular Lens (P910056/S032) | Bausch & Lomb, Inc. | 2019-07-03 |
| ARCHITECT AUSAB (P050051/S035) | Abbott Laboratories, Inc. | 2019-07-03 |
| X Series®, R Series®, AED Pro®, AED 3 BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower (P160022/S010) | ZOLL Medical Corporation | 2019-07-03 |
| FluoroPerm 92, FluoroPerm 60, FluoroPerm 30, FluoroPerm 151, HDS and HDS 100 (P870024/S052) | CooperVision, Inc. | 2019-07-03 |
| Myopore Sutureless Myocardial Pacing Lead (P130012/S008) | Great Batch Medical | 2019-07-03 |
| NexGen LPS-Flex/LPS-Mobile Bearing Knee System (P060037/S060) | Zimmer, Inc. | 2019-07-03 |
| CapSure VDD-2 and Vitatron Brilliant S+VDD Lead (P890003/S415) | Medtronic, Inc. | 2019-07-02 |
| Tryton Side Branch Stent (P150039/S004) | Poseidon Medical, Inc. | 2019-07-02 |
| Precision Spectra, Precision Novi, Precision Montage, and Precision Montage MRI, Spectra WaveWriter Spinal Cord Stimulat (P030017/S326) | Boston Scientific Corp | 2019-07-02 |
| Gel-Flow NT, Gelfoam Powder, Gelfoam Sponge, Gelfoam Compressed Sponge (N18286/S032) | Pfizer, Inc. | 2019-07-02 |
| CoreValve Evolut R and CoreValve Evolut PRO transcatheter aortic valves (TAV) (P130021/S060) | Medtronic, Inc. | 2019-07-02 |
| +FLEX Active Electrode and Insertion Electrode (IE) FLEX (P000025/S106) | Med-El Corp. | 2019-07-02 |
| Nucleus 24 Cochlear Implant Sysstem (P970051/S186) | Cochlear Americas | 2019-07-02 |
| HeartWare HVAD System (P100047/S134) | Medtronic | 2019-07-02 |
| enVista One Piece Hydrophobic Acrylic Intraocular Lens (P910056/S036) | Bausch & Lomb, Inc. | 2019-07-02 |
| Nucleus Auditory Brainstem Implant System (P000015/S037) | Cochlear Americas | 2019-07-02 |
| CapSure Epicardial Pacing Lead (P950024/S086) | Medtronic, Inc. | 2019-07-02 |
| FoundationOne CDx (F1CDx) (P170019/S008) | Foundation Medicine, Inc. | 2019-07-01 |
| FoundationOne CDx (P170019/S004) | Foundation Medicine, Inc. | 2019-07-01 |
| Impella RP System (P170011/S013) | Abiomed, Inc. | 2019-06-28 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0 and Impella LD Systems (P140003/S053) | Abiomed, Inc. | 2019-06-28 |
| AUGMENT Bone Graft and AUGMENT Injectable (P100006/S007) | Biomimetic Therapeutics, LLC | 2019-06-28 |
| Avalus Bioprosthesis (P170006/S014) | Medtronic, Inc. | 2019-06-28 |
| Restylane and Perlane (P040024/S104) | Q-Med AB | 2019-06-28 |
| Spectranetics Laser Sheath (SLS) II and GlideLight Laser Sheath (P960042/S066) | Spectranetics (Philips) | 2019-06-28 |
| Impella 5.0/LD (P140003/S054) | Abiomed, Inc. | 2019-06-28 |
| Impella RP System (P170011/S012) | Abiomed, Inc. | 2019-06-28 |
| Exablate Model 4000 System (P150038/S009) | Insightec | 2019-06-28 |
| HeartWare Left Ventricular Assist Device System (P100047/S140) | Medtronic | 2019-06-28 |
| Natrelle 410 Highly Cohesive Anatomically Shaped Silicone Filled Breast Implants (P040046/S030) | Allergan | 2019-06-27 |
| Propel, Propel Mini and Propel Contour Sinus Implants (P100044/S042) | Intersect Ent. | 2019-06-27 |
| Artic Front Advance Pro Cardiac Cryoablation Catheter (P100010/S093) | Medtronic Cryocath, LP | 2019-06-27 |
| TECNIS CL Foldable Silicone Intraocular Lens (P880081/S043) | Johnson & Johnson Surgical Vision, Inc. | 2019-06-27 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S046) | Medtronic, Inc. | 2019-06-27 |
| Natrelle Silicone Filled Breast Implants (P020056/S049) | Allergan | 2019-06-27 |
| Attain Performa Lead and Attain Stability Quad MRI Lead (P080006/S134) | Medtronic, Inc. | 2019-06-27 |
| HV Splitter/Adaptor Kit and Sprint Quattro Lead (P920015/S231) | Medtronic, Inc. | 2019-06-27 |
| Helistat, Helitene Absorbable Collagen Hemaostatic Agents (P850010/S089) | Integra LifeSciences Corporation | 2019-06-27 |
| Collastat Absorbable Collagen Hemostatic Sponge Collastat Absorbable Collagen Hemostatic-Microfibrillar Form (INSTAT) (P810006/S089) | Integra LifeSciences Corporation | 2019-06-27 |
| CollaCote, CollaTape, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S076) | Integra Lifesciences Corp. | 2019-06-27 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR/SR MRI IPG, Astra S DR/SR MRI IPG, Astra XT DR/SR MRI IPG, Attesta D (P980035/S597) | Medtronic, Inc. | 2019-06-26 |
| Attain StarFix Lead (P060039/S094) | Medtronic, Inc. | 2019-06-26 |
| CapSure VDD-2 Leadand Vitatron Brilliant S+ VDD Lead (P890003/S413) | Medtronic, Inc. | 2019-06-26 |
| TECNIS Symfony Toric Extended Range of Vision Intraocular Lens (P980040/S099) | Johnson & Johnson Surgical Vision, Inc. | 2019-06-26 |
| CapSureFix MRI Lead (P090013/S299) | Medtronic, Inc. | 2019-06-26 |
| Coaptite (P040047/S052) | Merz North America, Inc. | 2019-06-26 |
| CapSure Epicardial Pacing Lead (P950024/S085) | Medtronic, Inc. | 2019-06-26 |
| Eversense Continuous Glucose Monitoring System (P160048/S009) | Senseonics, Incorporated | 2019-06-26 |
| AtriCure Synergy Ablation System (P100046/S010) | AtriCure, Inc. | 2019-06-26 |
| Transvene CS/SVC Lead (P980050/S122) | Medtronic, Inc. | 2019-06-26 |
| Epicardial Patch Lead (P900061/S154) | Medtronic Cardiac Rhythm Disease Management | 2019-06-26 |
| Amplia MRI CRT-D, Amplia MRI Quard CRt-P, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia (P010031/S670) | Medtronic Cardiac Rhythm Disease Management | 2019-06-26 |
| CapSure Sense Lead, CapSure SP Novus Lead and VItatron Crystalline Lead (P830061/S170) | Medtronic Cardiac Rhythm Disease Management | 2019-06-26 |
| SelectSecure Lead (P030036/S110) | Medtronic Cardiac Rhythm Disease Management | 2019-06-26 |
| Myocardial Packing Lead (P120017/S018) | Medtronic, Inc. | 2019-06-26 |
| HV Splitter/Adaptor Kit, IS-1 Connector Port Pin Plug Kit, Transvene CS/SVC Lead and Sprint Quattro Lead (P920015/S232) | Medtronic, Inc. | 2019-06-26 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI DR/VR ICD, Primo MRI VR/DR ICD, Prot (P980016/S710) | Medtronic Cardiac Rhythm Disease Management | 2019-06-26 |
| CapSureFix Lead, CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead (P930039/S199) | Medtronic, Inc. | 2019-06-26 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S069) | Syncardia Systems, LLC | 2019-06-26 |
| CapSure SP Novus Lead, CapSure Sp Z Lead, CapSure Z Novus Lead and Vitatron Impulse II Lead (P850089/S141) | Medtronic Cardiac Rhythm Disease Management | 2019-06-26 |
| Micra TPS (P150033/S055) | Medtronic, Inc. | 2019-06-26 |
| Attain Bipolar OTW Lead, Attain OTW LV Lead, COnsulat CRT-P, Percepa Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena B (P010015/S409) | Medtronic, Inc. | 2019-06-26 |
| Juvederm Injectable Gel Implants (P050047/S071) | Allergan | 2019-06-26 |
| Bellafill Dermal Filler (P020012/S020) | Tiger Aesthetics Medical, LLC | 2019-06-26 |
| Juvederm Injectable Gel Implants (P110033/S046) | Allergan | 2019-06-26 |
| Dimension Vista TPSA Flex reagent cartridge (K6452) (P020027/S036) | Siemens Healthcare Diagnostics | 2019-06-26 |
| Attain Ability Lead, Attain Performa Lead and Attain Stability Quad MRI Lead (P080006/S135) | Medtronic, Inc. | 2019-06-26 |
| Dimension Vista TPSA Flex reagent cartridge (K6451) (P000021/S041) | Siemens Healthcare Diagnostics | 2019-06-26 |
| Alinity i AFP Assay (P120008/S011) | Abbott Laboratories | 2019-06-25 |
| NeuroPace RNS System (P100026/S072) | NeuroPace, Inc. | 2019-06-24 |
| CapSure Sense Lead, CapSure SP Novus Lead and Vitatron Crystalline Lead (P830061/S172) | Medtronic Cardiac Rhythm Disease Management | 2019-06-24 |
| Attain Bipolar OTW Lead and Attain OTW LV Lead (P010015/S412) | Medtronic, Inc. | 2019-06-24 |
| HV Splitter/Adaptor kit and Sprint Quattro Lead (P920015/S233) | Medtronic, Inc. | 2019-06-24 |
| HeartLight Endoscopic Ablation System (P150026/S006) | Cardiofocus, Inc. | 2019-06-24 |
| Activa Deep Brain Stimulation Therapy System (P960009/S347) | Medtronic, Inc. | 2019-06-24 |
| CapSure VDD-2 Lead and Vitatron Brilliant S+VDD Lead (P890003/S414) | Medtronic, Inc. | 2019-06-24 |
| Lutonix 035 Drug Coated Balloon PTA Catheter (P170003/S008) | Lutonix | 2019-06-24 |
| CapSureFix MRI Lead (P090013/S300) | Medtronic, Inc. | 2019-06-24 |
| CapSureFix Lead, CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead (P930039/S201) | Medtronic, Inc. | 2019-06-24 |
| Attain StarFix Lead (P060039/S095) | Medtronic, Inc. | 2019-06-24 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead and Vitatron Impulse II Lead (P850089/S142) | Medtronic Cardiac Rhythm Disease Management | 2019-06-24 |
| Attain Ability Lead and Attain Performa Lead (P080006/S136) | Medtronic, Inc. | 2019-06-24 |
| LifeVst Wearable Defibrillator (P010030/S118) | Zoll Manufacturing Corporation | 2019-06-24 |
| LOTUS Edge Valve System (P180029/S004) | Boston Scientific Corporation | 2019-06-22 |
| CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (P010031/S669) | Medtronic Cardiac Rhythm Disease Management | 2019-06-21 |
| MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM (P010015/S408) | Medtronic, Inc. | 2019-06-21 |
| MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE (P980035/S596) | Medtronic, Inc. | 2019-06-21 |
| PRECISE PRO RX Nitinol Stent System (P030047/S039) | Cordis US Corporation | 2019-06-21 |
| NG3 and NG4 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) (P010012/S505) | Boston Scientific Corp | 2019-06-21 |
| VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS (P980016/S709) | Medtronic Cardiac Rhythm Disease Management | 2019-06-21 |
| NG3 and NG4 Implantable Cardioverter Defibrillators (ICDs) (P960040/S439) | Boston Scientific | 2019-06-21 |
| S.M.A.R.T. AND S.M.A.R.T. CONTROL Nitinol Stent System (P020036/S041) | Cordis US Corporation | 2019-06-21 |
| INCRAFT(R) AAA Stent Graft System (P150002/S004) | Cordis US Corporation | 2019-06-21 |
| Accolade Pacemakers (N970003/S240) | Boston Scientific Corp | 2019-06-21 |
| Mynx CONTROL Vascular Closure Device (P040044/S084) | Cordis US Corporation | 2019-06-21 |