| IdentiTi Porous Ti Interbody System (K183705) | Alphatec Spine, Inc. | 2019-03-01 |
| EP-TRACER System (K183266) | Schwarzer Cardiotek GmbH | 2019-03-01 |
| DTX Studio design (K181932) | Nobel Biocare AB | 2019-03-01 |
| Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation Applicator (14cm), , Solero microwave Tissue Ablation Applicator (19cm), Solero microwave Tissue Ablation Applicator (29cm) (K182250) | AngioDynamics, Inc. | 2019-02-28 |
| Digital Thermometer (K182629) | Joytech Healthcare Co. , Ltd. | 2019-02-28 |
| Lifetech Cardio Model 8301 Temporary Pacemaker (K182839) | Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. | 2019-02-28 |
| Austin Miller Large External Fixation System (K181528) | Austin Miller Trauma, LLC | 2019-02-28 |
| QUANTIEN Measurement System (K183099) | St. Jude Medical (Now Abbott Medical) | 2019-02-28 |
| EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) (K183313) | Euroimmun Us, Inc. | 2019-02-28 |
| FUJIFILM Endoscope Model EG-530N (K183686) | Fujifilm Corporation | 2019-02-28 |
| ReDS System (K180479) | Sensible Medical Innovations , Ltd. | 2019-02-28 |
| PAT (Pain Alleviation Technologies) (K182267) | Marchan Medical, LLC | 2019-02-27 |
| Lympha Press Optimal Plus (K182003) | Mego Afek AC , Ltd. | 2019-02-27 |
| FlowMet-R (K182494) | Laser Associated Sciences, Inc. | 2019-02-27 |
| EzDent-i / E2 / Prora View (K190087) | Ewoosoft Co., Ltd. | 2019-02-27 |
| FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5 (K183683) | Fujifilm Corporation | 2019-02-27 |
| uPMR 790 (K183014) | Shanghai United Imaging Healthcare Co., Ltd. | 2019-02-27 |
| FibermarX Radiopaque Tissue Marker (K190155) | Viscus Biologics, LLC | 2019-02-27 |
| AeroPro Cordless Prophy System (K180682) | Premier Dental Company Products | 2019-02-27 |
| Body System (K182440) | A-1 Engineering | 2019-02-26 |
| VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 – >=64/8 µg/mL) (K183360) | bioMerieux, Inc. | 2019-02-26 |
| Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use (K181870) | Wuhan W.E.O Science & Technology Development Co., Ltd. | 2019-02-26 |
| ClariFix (K190356) | Arrinex, Inc. | 2019-02-26 |
| HEALIX ADVANCE SP PEEK Anchor (K182941) | Medos International SARL | 2019-02-26 |
| Omni Instrument Tray (K182052) | Hologic, Inc. | 2019-02-26 |
| Tyece OTC EMS System (K183454) | Tyece , Ltd. | 2019-02-26 |
| GrayDuck Stent (K183374) | Poll Medical, LLC | 2019-02-26 |
| 3M Comply Hydrogen Peroxide Chemical Indicator (K183211) | 3M Company | 2019-02-26 |
| CAPERE Thrombectomy System (K183179) | Vascular Medcure, Inc. | 2019-02-25 |
| COBRA Fusion Ablation System (K190151) | AtriCure, Inc. | 2019-02-25 |
| Zap-X Radiosurgery System (K183698) | Zap Surgical Systems | 2019-02-25 |
| Perla® Posterior Cervico-Thoracic Fixation System (K190071) | Spineart | 2019-02-25 |
| Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200 (K183290) | Thrombolex, Inc. | 2019-02-25 |
| SpringTMS (K182976) | Eneura®, Inc. | 2019-02-25 |
| IRIS 1.0 System (K182643) | Intuitive Surgical | 2019-02-22 |
| Altus Spine Interbody Fusion System (K182406) | Altus Partners, LLC | 2019-02-22 |
| Reprocessed Response Diagnostic Electrophysiology Catheter (K182488) | Innovative Health, LLC | 2019-02-22 |
| Doctor Tecar (K183693) | Mectronic Medicale S.R.L. | 2019-02-22 |
| Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes (K183640) | Mauna Kea Technologies | 2019-02-22 |
| FUJIFILM Ultrasonic Endoscope (K182825) | Fujifilm Corporation | 2019-02-22 |
| Libertas Acetabular Hooded Liner (K183365) | Maxx Orthopedics, Inc. | 2019-02-22 |
| EMMA 1.5T MRI System (K183621) | Time Medical Limited | 2019-02-22 |
| DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette (K181551) | Runbio Biotech Co.,Ltd | 2019-02-22 |
| Empower RF Catheter (K183240) | Broncus Medical, Inc. | 2019-02-22 |
| HeartCheck Cardi Beat ECG Monitor with GEMS Mobile (K181310) | Cardiocomm Solutions, Inc. | 2019-02-22 |
| Choice Spine Hawkeye Vertebral Body Replacement (VBR) System (K183588) | Choicespine | 2019-02-22 |
| The EPAD 2 System (K182542) | Safeop Surgical, Inc. | 2019-02-22 |
| Babyleo TN500 (K182859) | Dragerwerk AG & CO Kgaa | 2019-02-22 |
| Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device (K182578) | Devon Medical Products (Jiangsu), Ltd. | 2019-02-21 |
| NobelParallel Conical Connection (K173418) | Nobel Biocare AB | 2019-02-21 |
| Coag-Sense Prothrombin Time (PT) / INR Monitoring Device (K183255) | Coagusense, Inc. | 2019-02-21 |
| Sensus Healthcare TVM Balloon Applicator (K190255) | Sensus Healthcare, Inc. | 2019-02-21 |
| Sensus TPS Workstation (K182665) | Sensus Healthcare, Inc. | 2019-02-21 |
| HEALIX Ti ANCHOR with DYNACORD (K183279) | Medos International SARL | 2019-02-21 |
| Sensus IORT System (K182641) | Sensus Healthcare, Inc. | 2019-02-21 |
| ZOOM Aspiration Pump (K190105) | Taiwan Biomaterial Co., Ltd. | 2019-02-21 |
| MRIdian Linac System (K181989) | Viewray, Incorporated | 2019-02-20 |
| AnyCheck IMT-100 (K180953) | Dms Co., Ltd. | 2019-02-20 |
| VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL) (K183415) | bioMerieux, Inc. | 2019-02-20 |
| Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire J-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration Hole, 28cm; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration, 36cm ; Laparoscopic Flat L-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Straight Spatula Electrode, Hollow, 28cm ; Laparoscopic Curved Spatula Electrode, Hollow, 28cm; Laparoscopic Wire J (K183594) | New Deantronics Taiwan , Ltd. | 2019-02-19 |
| Pressure Therapy System PT1003 (K181409) | Xiamen Senyang Co., Ltd. | 2019-02-19 |
| MIS Bunion System (K181872) | Crossroads Extremity Systems, LLC | 2019-02-19 |
| Vector Hammertoe Correction System (K183055) | Nvision Biomedical Technologies, LLC | 2019-02-19 |
| Byte Aligner System (K180346) | Straight Smile, LLC | 2019-02-19 |
| BrainScope TBI (Model: Ahead 400) (K183241) | Brainscope Company, Inc. | 2019-02-19 |
| TMS-Cobot TS MV (K182768) | Axilum Robotics | 2019-02-17 |
| Quo-Test A1c System (K180509) | Ekf-Diagnostic GmbH | 2019-02-16 |
| GEM Premier ChemSTAT (K183555) | Instrumentation Laboratory CO | 2019-02-16 |
| TEMA Elbow System (K181362) | Lima Corporate S.P.A. | 2019-02-16 |
| GEM Premier ChemSTAT (K183546) | Instrumentation Laboratory CO | 2019-02-16 |
| RX-1 Rhythm Express Remote Cardiac Monitoring System (K183704) | VivaQuant, Inc. | 2019-02-16 |
| Wu's Powered Wheelchair (K181163) | Wu'S Tech Co., Ltd. | 2019-02-16 |
| GEM Premier ChemSTAT (K183549) | Instrumentation Laboratory CO | 2019-02-16 |
| PREVENA RESTOR(TM) Incision Management System (K181507) | Kci USA, Inc. | 2019-02-15 |
| RS85 Diagnostic Ultrasound System (K182932) | Samsung Medison Co., Ltd. | 2019-02-15 |
| IPL Hair Removal Device (K183217) | Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. | 2019-02-15 |
| OsseOne Dental Implant System (K182293) | Synoross Dba Osseone | 2019-02-15 |
| oCare Wrist Pulse Oximeter (K183556) | Taiwan Biophotonic Corporation | 2019-02-15 |
| Lunderquist® Fixed Core Wire Guide (K181353) | Cook Incorporated | 2019-02-15 |
| CIRRUS HD-OCT (K181534) | Carl Zeiss Meditec, Inc. | 2019-02-15 |
| MAGNETOM Terra (K183222) | Siemens Medical Solutions USA, Inc. | 2019-02-15 |
| ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) (K183039) | Stryker GmbH | 2019-02-15 |
| PhantomMSK (K182332) | OrthoGrid Systems, Inc. | 2019-02-15 |
| Reliance Lumbar IBF System (K183049) | Reliance Medical Systems, LLC | 2019-02-15 |
| EndoFLIP System (K183072) | Crospon, Ltd. | 2019-02-15 |
| MAGNETOM Aera (K190138) | Siemens Medical Solutions USA, Inc. | 2019-02-15 |
| 3M Comply Hydrogen Peroxide Indicator Tape (K183209) | 3M Company | 2019-02-15 |
| Stabil Orthopaedic Solutions Total Knee System (K183225) | Stabil Orthopaedic Solutions, LLC | 2019-02-15 |
| Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP (K181393) | Valmed S.R.L. | 2019-02-15 |
| SpiroSphere (K173937) | Eresearchtechnology GmbH | 2019-02-15 |
| SmartMouth DryMouth Oral Rinse (K181194) | Triumph Pharmaceuticals, Inc. | 2019-02-15 |
| Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 ug/mL (K183324) | Thermo Fisher Scientific | 2019-02-15 |
| GMC Wrist Automatic Blood Pressure Monitor (K181930) | Gmc, Inc. | 2019-02-14 |
| Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing (K181315) | Winner Medical Co., Ltd. | 2019-02-14 |
| MAGNETOM Amira, MAGNETOM Sempra (K183221) | Siemens Medical Solutions USA, Inc. | 2019-02-14 |
| t:slim X2 insulin pump with interoperable technology (DEN180058) | Tandem Diabetes Care, Inc. | 2019-02-14 |
| HEALIX ADVANCE Anchor with DYNACORD Suture (K183506) | Medos International SARL | 2019-02-14 |
| DynaNail Mini (K182677) | MedShape, Inc. | 2019-02-14 |
| MyoStrain 5.1 (K182756) | Myocardial Solutions | 2019-02-14 |
| Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker (K183196) | Stryker Corporation | 2019-02-14 |