| Shoreline Cervical Interbody RT System (K183083) | SeaSpine Orthopedics Corporation | 2019-02-14 |
| Ion Endoluminal System ; Flexision Biopsy Needle (K182188) | Intuitive Surgical | 2019-02-14 |
| Dexcom G6 Continuous Glucose Monitoring System (K183206) | Dexcom, Inc. | 2019-02-14 |
| AdvantageRib System (K183317) | Sig Medical Corporation | 2019-02-14 |
| Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems (K183063) | Philips Medical Systems Nederland B.V. | 2019-02-14 |
| Presero 3D Scanning System (K190074) | Certis Health | 2019-02-14 |
| Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups (K182705) | B-One Ortho, Corp. | 2019-02-14 |
| PhotoFix Decellularized Bovine Pericardium (K183635) | Cryolife, Inc. | 2019-02-14 |
| DD cube ONE ML (K183569) | Dental Direkt GmbH | 2019-02-14 |
| QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System (K181661) | Bio-Rad Laboratories, Inc. | 2019-02-13 |
| Fenom Pro Nitric Oxide Test (K182874) | Spirosure, Inc. | 2019-02-13 |
| SnapShot Freeze 2 (K183161) | Ge Medical Systems, LLC | 2019-02-13 |
| Kava and Kava with Herbst (K182661) | Sketchpad Innovations, LLC | 2019-02-13 |
| NuVasive Reline System (K182974) | Nu Vasive, Incorporated | 2019-02-13 |
| U&U Blood Collection Sets (K181508) | U&U Medical Technology Co, Ltd. | 2019-02-13 |
| ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube (K182915) | Envizion Medical , Ltd. | 2019-02-13 |
| EPIC Extremity Fusion Plate System (K182991) | Epic Extremity, LLC | 2019-02-13 |
| WiEMSpro (K181955) | Medical Cables S.L. | 2019-02-12 |
| Aurora Evacuator (K190075) | Rebound Therapeutics | 2019-02-12 |
| Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens; Boston XO (hexafocon A) Rigid Gas Permeable Contact Lens; Boston XO2 (hexafocon B) Rigid Gas Permeable Contact Lens (K183167) | Bausch & Lomb, Incorporated | 2019-02-12 |
| FORA P100 Blood Pressure Monitoring System (K182934) | Taidoc Technology Corporation | 2019-02-12 |
| Cruxcan (CRX-1000) (K183637) | Cruxell Corp. | 2019-02-12 |
| MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8ug/mL) (K183127) | Beckman Coulter, Inc. | 2019-02-12 |
| KOWA VK-2s (K190056) | Kowa Co. Ltd. Chofu | 2019-02-12 |
| Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode (K183375) | Horiba, Ltd. | 2019-02-12 |
| Journey II Unicompartmental Knee System (K190085) | Smith & Nephew, Inc. | 2019-02-11 |
| BacT/ALERT FA Plus; BacT/ALERT PF Plus (K183166) | bioMerieux, Inc. | 2019-02-11 |
| easyPPHTM Hemorrhoidal Stapler for Single Use (K183477) | Ezisurg Medical Co., Ltd. | 2019-02-11 |
| TrueDorsal Devices (K180691) | True Function Laboratory, Inc. | 2019-02-11 |
| Athena II Cervical Plate System (K183409) | Medyssey USA, Inc. | 2019-02-11 |
| Elitone Device (K183585) | Elidah, Inc. | 2019-02-11 |
| IntraSight (K190078) | Volcano Corporation | 2019-02-11 |
| HANAROSTENT FASTTM Biliary (NNN) (K183396) | M.I.Tech Co., Ltd. | 2019-02-11 |
| Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device (K183557) | Titan Spine, Inc. | 2019-02-11 |
| Cemented TSI Hip Stem (K181340) | Signature Orthopaedics Pty, Ltd. | 2019-02-11 |
| SMG Anterior Cervical Plate System (K183073) | Sapphire Medical Group | 2019-02-11 |
| Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4, Infant Coil – 24, Cardiac Coil – 24, Foot & Ankle Coil - 24 (K183186) | Shanghai United Imaging Healthcare Co., Ltd. | 2019-02-08 |
| LINK MP Monoblock Hip Prosthesis (K183141) | Waldemar Link GmbH & Co. KG | 2019-02-08 |
| Coala Heart Monitor (K182040) | Coala Life AB | 2019-02-08 |
| Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush (K181317) | Wilson-Cook Medical, Inc. | 2019-02-08 |
| Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line (K181467) | Oridion Medical 1987 , Ltd. | 2019-02-08 |
| Ammonia II (K183517) | Roche Diagnostics Operations (Rdo) | 2019-02-08 |
| Keeler TonoCare Tonometer (K181143) | Keeler Instruments, Inc. | 2019-02-08 |
| Carestream DRX-1 System with DRX Plus 2530 Detectors (K183245) | Carestream Health, Inc. | 2019-02-08 |
| ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer (K182833) | The Argen Corporation | 2019-02-08 |
| SEKURE Acetaminophen L3K Assay (K180835) | Sekisui Diagnostics P.E.I., Inc. | 2019-02-08 |
| ArcTV Transvaginal Sling System (K183134) | Urocure, LLC | 2019-02-07 |
| ROSA ONE Brain Application (K182417) | Medtech S.A | 2019-02-07 |
| AcQMap High Resolution Imaging and Mapping System (K181577) | Acutus Medical, Inc. | 2019-02-07 |
| Biomet Headless Compression and Twist-Off Screws (K190035) | Biomet, Inc. | 2019-02-07 |
| SafeAir Smoke Evacuator compact (K182224) | Lina Medical Aps | 2019-02-07 |
| SonoSite SII Ultrasound System (K183235) | FUJIFILM Sonosite, Inc. | 2019-02-07 |
| Parcus GFS BTB (K183331) | Parcus Medical, LLC | 2019-02-07 |
| dpl SpotLite (K183118) | Led Technologies, Inc. | 2019-02-07 |
| Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal (K182259) | Acell, Inc. | 2019-02-07 |
| WavelinQ 4F EndoAVF System (K182796) | C.R. Bard, Inc. | 2019-02-06 |
| RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4 (K182102) | Olympus Medical Systems Corp. | 2019-02-06 |
| Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™ Anterior Cervical Plate, Venture™ Anterior Cervical Plate, Zephir™ Anterior Cervical Plate System and Zevo™ Anterior Cervical Plate System (K182885) | Medtronic Sofamor Danek USA, Inc. | 2019-02-06 |
| SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments (K183119) | Globus Medical, Inc. | 2019-02-06 |
| CO2 Sampling Line (K181981) | Tylenol Medical Instruments Co., Ltd. | 2019-02-06 |
| Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black (K183435) | Ethicon Endo-Surgery, LLC | 2019-02-06 |
| DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives (K190045) | Alcon Laboratories, Inc. | 2019-02-06 |
| Omnia Medical Rotary PLIF System (K183659) | Omnia Medical, LLC | 2019-02-06 |
| PRECICE® BONE TRANSPORT™ System (K182170) | Nuvasive Specialized Orthopedics, Inc. | 2019-02-05 |
| Spectra Optia Apheresis System (K183081) | Terumobct, Inc. | 2019-02-05 |
| Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs (K183132) | O&M Halyard, Inc. | 2019-02-05 |
| Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix (K183163) | Motiva USA, LLC | 2019-02-05 |
| JADE Mobile X-Ray (K183388) | DRGEM Corporation | 2019-02-05 |
| JUSHA-C270G/ JUSHA-C270/ C270G/ C270 LCD Monitor (K183498) | Nanjing Jusha Display Technology Co., Ltd. | 2019-02-05 |
| Absoanchor Microimplant (K181142) | Dentos, Inc. | 2019-02-05 |
| JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor (K183499) | Nanjing Jusha Display Technology Co., Ltd. | 2019-02-04 |
| Velofix Interbody Fusion System (K190067) | U&I Corporation | 2019-02-04 |
| d-Nav System (K181916) | Hygieia, Inc. | 2019-02-04 |
| Capture-CMV (K183571) | Immucor, Inc. | 2019-02-04 |
| EIT Cellular Titanium Lumbar Cage - T/PLIF (K183447) | Eit Emerging Implant Technologies GmbH | 2019-02-04 |
| Glo-Tip Spray Catheter (K182319) | Wilson-Cook Medical, Inc. | 2019-02-01 |
| HemoCue Hb 801 System (K181751) | Hemocue AB | 2019-02-01 |
| Invia Abdominal Dressing Kit (K182191) | Medela AG | 2019-02-01 |
| AI Rad Companion (Engine) (K183272) | Siemens Medical Solutions USA, Inc. | 2019-02-01 |
| Family of Venus RF Systems - Heal (K182094) | Venus Concept USA, Inc. | 2019-02-01 |
| Supria True64 Whole-Body X-Ray CT System (K183291) | Hitachi Healthcare Americas | 2019-02-01 |
| Pedimax II - Pedicular Screw Spinal System (K180626) | Gm Dos Reis Industria E Comerico Ltda. | 2019-02-01 |
| DR 800 with Tomosynthesis (K183275) | Agfa N.V. | 2019-02-01 |
| easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular Stapler for Single Use (K181657) | Ezisurg Medical Co., Ltd. | 2019-02-01 |
| Endoscope Sterilization Tray (K183139) | Intuitive Surgical, Inc. | 2019-02-01 |
| HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High (K182744) | Eurotrol B.V. | 2019-02-01 |
| SECULOK™ ACP System (K190053) | U&I Corporation | 2019-02-01 |
| Vbeam Prima Laser System (K183452) | Candela Corp. | 2019-02-01 |
| iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) (K181070) | Andon Health Co, Ltd. | 2019-02-01 |
| STRONG Dental Handpieces (K181129) | Saeshin Precision Co., Ltd. | 2019-01-31 |
| Panoura X-ERA PF/NF/MF (K182198) | The Yoshida Dental Mfg. Co., Ltd. | 2019-01-31 |
| Endosee System (K183020) | CooperSurgical, Inc. | 2019-01-31 |
| SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900 (K182827) | STERIS Corporation | 2019-01-31 |
| Boston Keratoprosthesis, Type I Lucia (K182986) | Massachusetts Eye and Ear Infirmary D/B/A Boston | 2019-01-30 |
| Patient Cables and Leadwires , Disposable ECG Leadwires (K182327) | Orantech, Inc. | 2019-01-30 |
| Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid (K183696) | Tornier, Inc. | 2019-01-30 |
| Zimmer Segmental System Proximal Femoral Component (K183136) | Zimmer, Inc. | 2019-01-30 |
| MOTO Partial Knee System (K183029) | Medacta International S.A. | 2019-01-30 |
| FastPack IP Sex Hormone Binding Globulin Immunoassay (K182521) | Qualigen, Inc. | 2019-01-29 |
| X5 Series Digital Color Doppler Ultrasound System (K182648) | Sonoscape Medical Corp. | 2019-01-29 |