| K183279 — HEALIX Ti ANCHOR with DYNACORD | Medos International SARL Feb 21, 2019 |
| K182578 — Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device | Devon Medical Products (Jiangsu), Ltd. Feb 21, 2019 |
| K182665 — Sensus TPS Workstation | Sensus Healthcare, Inc. Feb 21, 2019 |
| K190255 — Sensus Healthcare TVM Balloon Applicator | Sensus Healthcare, Inc. Feb 21, 2019 |
| K190105 — ZOOM Aspiration Pump | Taiwan Biomaterial Co., Ltd. Feb 21, 2019 |
| K182641 — Sensus IORT System | Sensus Healthcare, Inc. Feb 21, 2019 |
| K183415 — VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL) | bioMerieux, Inc. Feb 20, 2019 |
| K180953 — AnyCheck IMT-100 | Dms Co., Ltd. Feb 20, 2019 |
| K181989 — MRIdian Linac System | Viewray, Incorporated Feb 20, 2019 |
| K181409 — Pressure Therapy System PT1003 | Xiamen Senyang Co., Ltd. Feb 19, 2019 |
| K183055 — Vector Hammertoe Correction System | Nvision Biomedical Technologies, LLC Feb 19, 2019 |
| K180346 — Byte Aligner System | Straight Smile, LLC Feb 19, 2019 |
| K183594 — 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 | New Deantronics Taiwan , Ltd. Feb 19, 2019 |
| K183241 — BrainScope TBI (Model: Ahead 400) | Brainscope Company, Inc. Feb 19, 2019 |
| K181872 — MIS Bunion System | Crossroads Extremity Systems, LLC Feb 19, 2019 |
| K182768 — TMS-Cobot TS MV | Axilum Robotics Feb 17, 2019 |
| K181163 — Wu's Powered Wheelchair | Wu'S Tech Co., Ltd. Feb 16, 2019 |
| K183549 — GEM Premier ChemSTAT | Instrumentation Laboratory CO Feb 16, 2019 |
| K181362 — TEMA Elbow System | Lima Corporate S.P.A. Feb 16, 2019 |
| K183704 — RX-1 Rhythm Express Remote Cardiac Monitoring System | VivaQuant, Inc. Feb 16, 2019 |
| K183546 — GEM Premier ChemSTAT | Instrumentation Laboratory CO Feb 16, 2019 |
| K183555 — GEM Premier ChemSTAT | Instrumentation Laboratory CO Feb 16, 2019 |
| K180509 — Quo-Test A1c System | Ekf-Diagnostic GmbH Feb 16, 2019 |
| K181353 — Lunderquist® Fixed Core Wire Guide | Cook Incorporated Feb 15, 2019 |
| K181534 — CIRRUS HD-OCT | Carl Zeiss Meditec, Inc. Feb 15, 2019 |
| K182932 — RS85 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. Feb 15, 2019 |
| K183225 — Stabil Orthopaedic Solutions Total Knee System | Stabil Orthopaedic Solutions, LLC Feb 15, 2019 |
| K181507 — PREVENA RESTOR(TM) Incision Management System | Kci USA, Inc. Feb 15, 2019 |
| K183222 — MAGNETOM Terra | Siemens Medical Solutions USA, Inc. Feb 15, 2019 |
| K183049 — Reliance Lumbar IBF System | Reliance Medical Systems, LLC Feb 15, 2019 |
| K181393 — Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP | Valmed S.R.L. Feb 15, 2019 |
| K183324 — 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 | Thermo Fisher Scientific Feb 15, 2019 |
| K182293 — OsseOne Dental Implant System | Synoross Dba Osseone Feb 15, 2019 |
| K181194 — SmartMouth DryMouth Oral Rinse | Triumph Pharmaceuticals, Inc. Feb 15, 2019 |
| K182332 — PhantomMSK | OrthoGrid Systems, Inc. Feb 15, 2019 |
| K183556 — oCare Wrist Pulse Oximeter | Taiwan Biophotonic Corporation Feb 15, 2019 |
| K173937 — SpiroSphere | Eresearchtechnology GmbH Feb 15, 2019 |
| K183209 — 3M Comply Hydrogen Peroxide Indicator Tape | 3M Company Feb 15, 2019 |
| K183217 — IPL Hair Removal Device | Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. Feb 15, 2019 |
| K183072 — EndoFLIP System | Crospon, Ltd. Feb 15, 2019 |
| K190138 — MAGNETOM Aera | Siemens Medical Solutions USA, Inc. Feb 15, 2019 |
| K183039 — ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) | Stryker GmbH Feb 15, 2019 |
| DEN180058 — t:slim X2 insulin pump with interoperable technology | Tandem Diabetes Care, Inc. Feb 14, 2019 |
| K190074 — Presero 3D Scanning System | Certis Health Feb 14, 2019 |
| K183221 — MAGNETOM Amira, MAGNETOM Sempra | Siemens Medical Solutions USA, Inc. Feb 14, 2019 |
| K182705 — Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups | B-One Ortho, Corp. Feb 14, 2019 |
| K183317 — AdvantageRib System | Sig Medical Corporation Feb 14, 2019 |
| K183206 — Dexcom G6 Continuous Glucose Monitoring System | Dexcom, Inc. Feb 14, 2019 |
| K182188 — Ion Endoluminal System ; Flexision Biopsy Needle | Intuitive Surgical Feb 14, 2019 |
| K183569 — DD cube ONE ML | Dental Direkt GmbH Feb 14, 2019 |