| ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010 (K183070) | Asahi Intecc Co., Ltd. | 2019-01-29 |
| Cortex CAD/CAM Abutments (K181580) | Cortex Dental Implants Industries , Ltd. | 2019-01-29 |
| T-PLUS (K181893) | Wintecare SA | 2019-01-29 |
| AQrate Robotic Assistance System (K182000) | Globus Medical, Inc. | 2019-01-29 |
| Neo Cage System TM (K181048) | Neo Medical SA | 2019-01-29 |
| Solitaire 4 Revascularization Device (K183022) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2019-01-29 |
| ZOLL ECG Analysis Software (K182093) | Zoll Manufacturing Corporation | 2019-01-28 |
| Venue GO (K183362) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2019-01-28 |
| Cervical Spacer (K182477) | Additive Implants, LLC | 2019-01-28 |
| MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component (K183025) | B-One Ortho, Corp. | 2019-01-28 |
| WEGO-PGLA RAPID (K183001) | Foosin Medical Supplies Inc., Ltd. | 2019-01-28 |
| WEGO-PGA RAPID (K183004) | Foosin Medical Supplies Inc., Ltd. | 2019-01-28 |
| MIS LOCKiT Abutments System, OT-Equators and Ball Attachments (K182228) | Mis Implants Technologies , Ltd. | 2019-01-28 |
| VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System (K180822) | Wenzel Spine, Inc. | 2019-01-28 |
| Quantum Blood and IV Fluid Infusion Warmer (K181775) | Life Warmer, Inc. | 2019-01-28 |
| Aloka Arietta 850 (K183456) | Hitachi Healthcare Americas | 2019-01-28 |
| Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow (K181307) | Zimmer, Inc. | 2019-01-28 |
| Greenmedi Safety Filter Syringe (K173743) | Sang-A Frontec Co., Ltd. | 2019-01-28 |
| Revive Reusable Bladder Support (K183468) | Rinovum Subsidiary 2, LLC | 2019-01-25 |
| NEST Interbody System (K180230) | Paonan Biotech Co., Ltd. | 2019-01-25 |
| Hoffmann LRF System (K182968) | Stryker GmbH | 2019-01-25 |
| medi pneumatic compression system (pcs) – brio (Model 651) (K183631) | Medi USA, LP | 2019-01-25 |
| MiniCollect K2E K2EDTA Tubes (K182078) | Greiner Bio-One Na, Inc. | 2019-01-25 |
| Sysmex XN-L Automated Hematology Analyzer (K182389) | Sysmex America, Inc. | 2019-01-25 |
| Treace Medical Concepts (TMC) Plating System (K183321) | Treace Medical Concepts, Inc. | 2019-01-25 |
| Earlens Contact Hearing Aid (K182480) | Earlens Corporation | 2019-01-25 |
| Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle (K183615) | Avenu Medical, Inc. | 2019-01-25 |
| Accucuff Cuff Pressure Indicator (K182548) | Tianjin Medis Medical Device Co., Ltd. | 2019-01-25 |
| GenesisZr™ 4Y Zirconia (K182642) | United Dental Resources Corporation | 2019-01-25 |
| SI-Restore® Sacroiliac Joint Fixation System (K182919) | Biofusion Medical | 2019-01-25 |
| SMR Lateralized Connectors with screws (K183042) | Lima Corporate S.P.A. | 2019-01-25 |
| microINR System (K180780) | Iline Microsystems, S.L. | 2019-01-25 |
| Wilson-Cook Achalasia Balloon (K182895) | Wilson-Cook Medical, Inc. | 2019-01-25 |
| HammerToe Compression System (K183228) | Paragon 28, Inc. | 2019-01-25 |
| Reprocessed CS Diagnostic Electrophysiology Catheter (K181056) | Stryker Sustainability Solutions | 2019-01-24 |
| BTL-703 (K182363) | BTL Industries, Inc. | 2019-01-24 |
| Ritter Dental Implant System (K180183) | Ritter Implants GmbH & Co. KG | 2019-01-24 |
| MAGNETOM Lumina (K183244) | Siemens Medical Solutions USA, Inc. | 2019-01-24 |
| Zyppah Anti-Snoring Device (K182312) | Always More Marketing | 2019-01-24 |
| Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay (K181135) | Immunalysis Corporation | 2019-01-24 |
| FLOW 90 Wand (K183346) | ArthroCare Corporation | 2019-01-24 |
| ProRad 2FC and ProRad 3NC Stationary Radiographic Systems (K183541) | Prognosys Medical Systems Private Limited | 2019-01-24 |
| Surveyor S2 (K182297) | Mortara Instrument, Inc. | 2019-01-24 |
| Surgical Face Mask (K182514) | Xiantao Zhibo Non-Woven Products Co., Ltd. | 2019-01-24 |
| E-CUBE i7 (K182594) | Alpinion Medical Systems Co., Ltd. | 2019-01-24 |
| ROSA Knee System (K182964) | Orthosoft Inc (D/B/A Zimmer Cas) | 2019-01-24 |
| Aptima Mycoplasma genitalium Assay (DEN180047) | Hologic, Inc. | 2019-01-23 |
| Optilite IgA CSF Kit (K183151) | The Binding Site Group , Ltd. | 2019-01-23 |
| SPY Elite Intraoperative Perfusion Assessment System (K182907) | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2019-01-23 |
| Masimo MightySat Rx Fingertip Pulse Oximeter (K181956) | Masimo Corporation | 2019-01-23 |
| Pre-Formed Penile Silicone Block (K181387) | International Medical Devices, Inc. | 2019-01-23 |
| EZStart Interference Screw (K182955) | Conmed Corporation | 2019-01-22 |
| AMD Anti-Fog Solution (K181887) | Advanced Medical Design Co., Ltd. | 2019-01-22 |
| SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller (K183636) | Boston Scientific Corporation | 2019-01-22 |
| Freedom Ultra-Congruent CR Tibial Liner (K182574) | Maxx Orthopedics, Inc. | 2019-01-22 |
| S-Line (K182193) | Biocetec Co., Ltd. | 2019-01-22 |
| O-Scan (K183685) | Esaote, S.p.A. | 2019-01-22 |
| LG PRA.L DERMA LED MASK (K183671) | Lg Electronics.Inc | 2019-01-22 |
| FEMON Banana Thermometer (K180767) | Life Science Technology, Inc. | 2019-01-22 |
| M.U.S.T. Mini Extension (K182837) | Medacta International S.A. | 2019-01-22 |
| HM70A Diagnostic Ultrasound System (K182894) | Samsung Medison Co., Ltd. | 2019-01-22 |
| EUROPA™ Pedicle Screw System (K182970) | MiRus, LLC | 2019-01-22 |
| Compress and Mini Compress Anti-Rotation Spindles (K183553) | Biomet, Inc. | 2019-01-22 |
| Tigon Medical Tissue Anchors (K182507) | Tigon Medical | 2019-01-21 |
| XableCath Crossing Catheter (K183357) | Xablecath, Inc. | 2019-01-21 |
| Codman Disposable Perforators (K183581) | Integra Lifesciences Corp. | 2019-01-20 |
| ELAN 4 Tools (K182527) | Aesculap, Inc. | 2019-01-19 |
| SureForm 45, SureForm 45 Reloads (K183224) | Intuitive Surgical | 2019-01-18 |
| Magnetom Vida (K183254) | Siemens Medical Solutions USA, Inc. | 2019-01-18 |
| SIGNA Premier (K183231) | Ge Medical Systems, LLC | 2019-01-18 |
| AHMED ClearPath Glaucoma Drainage Device (K182518) | New World Medical, Inc. | 2019-01-18 |
| DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric (K182782) | Alcon Laboratories, Inc. | 2019-01-18 |
| Flex-THOR scope (K183264) | KARL STORZ Endoscopy-America, Inc. | 2019-01-18 |
| Aurora Surgiscope System (K182211) | Rebound Therapeutics Corporation | 2019-01-18 |
| MUTYH-Associated Polyposis (MAP) (K182784) | 23AndMe, Inc. | 2019-01-18 |
| PENTAX Video Colonoscopes (EC Family) (K181084) | Pentax of America, Inc. | 2019-01-18 |
| PICO 7Y Single Use Negative Pressure Wound Therapy System (K182323) | Smith & Nephew Medical Limited | 2019-01-18 |
| HardyDisk AST Omadacycline 30µg (OMC30) (K183298) | Hardy Diagnostics | 2019-01-18 |
| Cook Cystostomy Catheter Set (K181097) | Cook Incorporated | 2019-01-18 |
| MRI Compatibility for Existing Neodent Implant System (K182620) | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2019-01-18 |
| Puffin Lite Infant Resuscitation System (K182956) | International Biomedical | 2019-01-18 |
| Tyber Medical PT Interbody Spacer (K182284) | Tyber Medical, LLC | 2019-01-18 |
| Kurin PIV Blood Collection Set with High Pressure (K181895) | Kurin, Inc. | 2019-01-18 |
| Bright Guard (K181099) | Koncept Innovators, LLC | 2019-01-18 |
| VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES) (K180236) | Vr Medical Technology Co., Ltd. | 2019-01-18 |
| Responsive Arthroscopy Wedge Push-In Suture Anchors (K181076) | Responsive Arthroscopy, LLC | 2019-01-18 |
| Pristina Serena 3D (K182951) | GE Healthcare | 2019-01-18 |
| Reprocessed Visions PV .035 Digital IVUS Catheter (K181126) | Innovative Health, LLC | 2019-01-18 |
| Savina 300 (K180779) | Dragerwerk AG & CO Kgaa | 2019-01-17 |
| Bodycad Unicompartmental Knee System (K181302) | Bodycad Laboratories, Inc. | 2019-01-17 |
| Study Watch (K182456) | Verily Life Sciences, LLC | 2019-01-17 |
| Pinehurst Anterior Cervical Plate System (K181190) | Signature Orthopaedics Pty, Ltd. | 2019-01-17 |
| Imboki Knee Instrument System (K181338) | Signature Orthopaedics Pty, Ltd. | 2019-01-17 |
| Esprit Nova (K182227) | Neurozone Msh Incorporated | 2019-01-17 |
| DL Self-adhesive Electrode (K182111) | Shaoxing DL Healthcare Co., Ltd. | 2019-01-17 |
| CervAlign™ Anterior Cervical Plate System (K183060) | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2019-01-17 |
| VIVA combo RF System (K183538) | Starmed Co., Ltd. | 2019-01-17 |
| ProgenaMatrix (K182010) | Cell Constructs I, LLC | 2019-01-17 |
| Powder Free Nitrile Patient Examination Gloves, Blue Color (K181106) | Jiangsu Dongxin Medical Technology Co., Ltd. | 2019-01-16 |
| Merit RadialFlo Arterial Catheter (K182538) | Merit Medical Singapore Pte. , Ltd. | 2019-01-16 |