| Revanesse Versa, Revanesse Versa + (P160042/S004) | Prollenium Medical Technologies, Inc. | 2019-03-15 |
| Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat (P900033/S075) | Integra Lifesciences Corp. | 2019-03-15 |
| RESTYLANE Refyne and RESTYLANE Defyne (P140029/S016) | Q-Med AB | 2019-03-15 |
| TactiCath Quartz Contract Force Ablation Catheter (P130026/S040) | St Jude Medical | 2019-03-14 |
| MynxGrip, Mynx Ace and Mynx Control Vascular Closure Device (VCD) (P040044/S083) | Cordis US Corporation | 2019-03-14 |
| AcrySof Intraocular Lenses (P930014/S119) | Alcon Laboratories, Inc. | 2019-03-14 |
| Itrel and Intellis Spinal Cord Stimulation Systems (P840001/S420) | Medtronic Neuromodulation | 2019-03-14 |
| ALLEGRO Topolyzer VARIO and Patient Bed Swivel (P020050/S032) | Alcon Laboratories, Inc. | 2019-03-14 |
| TECNIS 3-Piece Multifocal (P080010/S018) | Johnson & Johnson Surgical Vision, Inc. | 2019-03-14 |
| CollaCote, CollaTape, CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S071) | Integra Lifesciences Corp. | 2019-03-14 |
| TECNIS 3-Piece Acrylic Monofocal (P990080/S049) | Johnson & Johnson Surgical Vision, Inc. | 2019-03-14 |
| Activa Deep Brain Stimulation Therapy System (P960009/S338) | Medtronic, Inc. | 2019-03-14 |
| Supera Peripheral Stent System (P120020/S022) | Abbott Vascular (Idef Technologies Inc) | 2019-03-14 |
| Vercise PC and Vercise Gevia Deep Brain Stimulation (DBS) Systems (P150031/S014) | Boston Scientific Corp | 2019-03-14 |
| INGEVITY Distal Tip Laser Weld Process (P150012/S072) | Boston Scientific | 2019-03-14 |
| MitraClip NT Clip Delivery System and MitraClip NTR/XTR Clip Delivery System (P100009/S028) | ABBOTT MEDICAL | 2019-03-14 |
| XACT Carotid Stent System (P040038/S035) | Abbott Vascular, Inc. | 2019-03-14 |
| Resolute Onyx RX Zotarolimus Eluting Coronary Stent System / Resolute Onyx OTW Zotarolimus Eluting Coronary Stent System (P160043/S018) | Medtronic Vascular | 2019-03-14 |
| SENSAR and TECNIS 1-Piece IOL, TECNIS OpticBlue IOL, TECNIS Multifocal 1-Piece IOL, TECNIS Symfony Extended Range of Vis (P980040/S101) | Johnson & Johnson Surgical Vision, Inc. | 2019-03-14 |
| WaveLight Analyzer II, ALLEGRO Topolyzer VARIO, Patient Bed Swivel (P030008/S028) | Alcon Laboratories, Inc. | 2019-03-14 |
| Implantable Cardioverter Defibrillator (P960040/S435) | Boston Scientific | 2019-03-13 |
| Juvederm Injectable Gel Implants (P050047/S066) | Allergan | 2019-03-13 |
| Edwards SAPIEN 3 Transcatheter Heart Valve and Accessories (P140031/S084) | Edwards Lifesciences, LLC | 2019-03-13 |
| LGW- Master Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal (P840001/S406) | Medtronic Neuromodulation | 2019-03-13 |
| PSW 1803.U /HMSC 3.40.2 / CardioMessenger Smart (P070008/S098) | Biotronik, Inc. | 2019-03-13 |
| Cardiac Resynchronization Therapy Defibrillator (P010012/S499) | Boston Scientific Corp | 2019-03-13 |
| DUROLANE (P170007/S002) | Bioventus, LLC | 2019-03-13 |
| LifeVest Wearable Defibrillator (P010030/S114) | Zoll Manufacturing Corporation | 2019-03-13 |
| PD-L1 IHC 28-8 pharmDx (P150025/S011) | Agilent Technologies, Inc. | 2019-03-13 |
| PSW 1803.U / HMSC 3.40.2 / CardioMessenger Smart (P950037/S197) | Biotronik, Inc. | 2019-03-13 |
| HeartWare Ventricular Assist System (HVAD) (P100047/S135) | Medtronic | 2019-03-13 |
| Helistat Absorbable Collagen Hemostatic Sponge/OraFOAM Absorbable Collagen Hemostatic Sponge (P850010/S082) | Integra LifeSciences Corporation | 2019-03-13 |
| Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S304) | ABBOTT MEDICAL | 2019-03-13 |
| Venovo Venous Stent System (P180037) | Bard Peripheral Vascular, Inc. | 2019-03-13 |
| Gel-One (P080020/S032) | Seikagaku Corp. | 2019-03-13 |
| Multilead Trial Cable (MLTC) (P140009/S045) | ABBOTT MEDICAL | 2019-03-13 |
| Real-Time REVEL System (P150019/S053) | Medtronic Minimed | 2019-03-13 |
| MiniMed 670G System (P160017/S055) | Medtronic Minimed, Inc. | 2019-03-13 |
| Activa Deep Brain Stimulation Therapy System (P960009/S324) | Medtronic, Inc. | 2019-03-13 |
| EGFR pharmDx (P030044/S007) | Agilent Technologies, Inc. | 2019-03-13 |
| HEMOBLAST Bellows (P170012/S015) | Dilon Technologies, Inc. | 2019-03-13 |
| PSW 1803.U / HMSC 3.40.2 /CardioMessenger Smart (P000009/S078) | Biotronik, Inc. | 2019-03-13 |
| Acticor 7 VR-T / Rivacor 7 VR-T /5VR-T /3 VR-T / Acticor 7 VR-T DX / Rivacor 7 VR-T DX /Rivacor 5 VR-T DX ; Acticor 7 DR (P050023/S125) | Biotronik, Inc. | 2019-03-13 |
| Vercise PC Deep and Vercise Geviarn Deep Brain Stimulation (DBS) Systems (P150031/S013) | Boston Scientific Corp | 2019-03-13 |
| LCS Total Knee System (P830055/S225) | Depuy, Inc. | 2019-03-13 |
| MiniMed 530G System (P120010/S128) | Medtronic, Inc. | 2019-03-13 |
| LCS Total Knee System (P830055/S223) | Depuy, Inc. | 2019-03-13 |
| Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs (P910023/S414) | ABBOTT MEDICAL | 2019-03-13 |
| PD-L1 IHC 22C3 PharmDx (P150013/S015) | Agilent Technologies, Inc. | 2019-03-13 |
| Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programmer Software (P140033/S041) | ABBOTT MEDICAL | 2019-03-13 |
| MiniMed 630G System (P150001/S059) | Medtronic Minimed | 2019-03-13 |
| Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ (P030054/S364) | ABBOTT MEDICAL | 2019-03-13 |
| Gel-One (P080020/S033) | Seikagaku Corp. | 2019-03-13 |
| Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S175) | ABBOTT MEDICAL | 2019-03-13 |
| iPro2 System (P150029/S026) | Medtronic Minimed | 2019-03-13 |
| CardioMEMS HF System (P100045/S035) | ABBOTT MEDICAL | 2019-03-13 |
| Guardian Connect System (P160007/S013) | Medtronic Minimed | 2019-03-13 |
| ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses (P890023/S036) | The Cooper Companies | 2019-03-12 |
| WATCHMAN Left Atrial Appendage Closure Device and Delivery System (P130013/S027) | Boston Scientific Corp | 2019-03-12 |
| Chorus Sound Processor and SoundWave Professional Suite 3.2/HiResolution Bionic Ear System (P960058/S132) | Advanced Bionics | 2019-03-12 |
| VNS Therapy System (P970003/S223) | LivaNova USA, Inc. | 2019-03-12 |
| MiniMed 630G System (P150001/S061) | Medtronic Minimed | 2019-03-11 |
| cobas 4800 HPV Master Mix (P100020/S043) | Roche Molecular Systems, Inc. | 2019-03-11 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S029) | ETHICON, Inc. | 2019-03-11 |
| Paradigm real-Time Rvel System (P150019/S054) | Medtronic Minimed | 2019-03-11 |
| Guardian Connect System (P160007/S015) | Medtronic Minimed | 2019-03-11 |
| MiniMed 670G System (P160017/S057) | Medtronic Minimed, Inc. | 2019-03-11 |
| MiniMed 530G System (P120010/S129) | Medtronic, Inc. | 2019-03-11 |
| iPro2 CGM System with Enlite Sensor (P150029/S027) | Medtronic Minimed | 2019-03-11 |
| Precision Spectra Spinal Cord Stimulatory (SCS) Sytem; Spectra WaveWriter Spinal Cord Stimulator (SCS) System; Precision (P030017/S322) | Boston Scientific Corp | 2019-03-11 |
| COLOGUARD (P130017/S026) | Exact Sciences Corporation | 2019-03-11 |
| Nucleus Auditory Brainstem Implant System (P000015/S035) | Cochlear Americas | 2019-03-08 |
| SynchroMed Infusion System Ascenda Intrathecal Catheters (P860004/S324) | Medtronic, Inc. | 2019-03-08 |
| Sprint Quattro Lead (P920015/S227) | Medtronic, Inc. | 2019-03-08 |
| Atellica IM Hepatitis B e Antigen (HBeAg) Assay (P090024/S006) | Siemens Healthcare Diagnostics | 2019-03-08 |
| Nucleus 24 Cochlear Implant System (P970051/S184) | Cochlear Americas | 2019-03-08 |
| VENTANA PD-L1(SP142) Assay. (P160002/S009) | Ventana Medical Systems, Inc. | 2019-03-08 |
| Atellica Im Anti-Hepatitis B core Total (HBcT) Assay (P040004/S015) | Siemens Healthcare Diagnostics | 2019-03-08 |
| InterStim Therapy System, Verify Evaluation System (P080025/S177) | Medtronic Neuromodulation | 2019-03-08 |
| Atellica IM Hepatitis B surface Antigen II (HBsII( and Atellica IM Hepatitis B surface Antigen 1 1 Comfirmatory *HBs11 C (P110041/S007) | Siemens Corp. | 2019-03-08 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent System (P110013/S094) | Medtronic Vascular | 2019-03-08 |
| Implantable System for Remodulin (P140032/S025) | Medtronic, Inc. | 2019-03-08 |
| comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S079) | CooperVision, Inc. | 2019-03-08 |
| ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses (P890023/S035) | The Cooper Companies | 2019-03-08 |
| Celsius RMT Catheter; Navistar RMT Thermocool Catheter; Celsius RMT Thermocool Catheter; Navistar RMT Catheter (P950005/S071) | Biosense Webster, Inc. | 2019-03-08 |
| HiResolution Bionic Ear System (P960058/S136) | Advanced Bionics | 2019-03-08 |
| Activa Deep Brain Stimulation Therapy System (P960009/S337) | Medtronic, Inc. | 2019-03-08 |
| Atellica IM Prostate-Specific Antigen (PSA) Assay (P950021/S017) | Siemens Healthcare Diagnostics | 2019-03-08 |
| Atellica IM Hepatitis C (aHCV) Assay (P030056/S014) | Siemens Healthcare Diagnostics | 2019-03-08 |
| Navistar RMT Catheter (P990025/S057) | Biosense Webster, Inc. | 2019-03-08 |
| Atellica IM Alpha Fetoprotein (AFP) Assay (P930036/S011) | Siemens Healthcare Diagnostics, Inc. | 2019-03-08 |
| LCS Total Knee System (P830055/S222) | Depuy, Inc. | 2019-03-08 |
| Navistar RMT Thermocool Catheter; Celsius Thermocool Catheter; Celsius RMT Thermocool Catheter (P030031/S096) | Biosense Webster, Inc. | 2019-03-08 |
| Navistar RMT Thermocool Catheter (P040036/S066) | Biosense Webster, Inc. | 2019-03-08 |
| HiResolution Bionic Ear System (P960058/S137) | Advanced Bionics | 2019-03-08 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant II Aorto-Uni-Iliac (AUI) Stent Graft System, Endur (P100021/S072) | Medtronic Vascular | 2019-03-08 |
| Atellica IM Complexed PSA (cPSA) Assay (P990055/S018) | Siemens Healthcare Diagnostics | 2019-03-08 |
| Nucleus Hybrid Implant System (P130016/S037) | Cochlear Americas | 2019-03-08 |
| Master Restore, Itrel, Synergy and IntellisM Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cor (P840001/S419) | Medtronic Neuromodulation | 2019-03-08 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System (P160043/S021) | Medtronic Vascular | 2019-03-08 |