| HbA1c Advanced (K182651) | Beckman Coulter Ireland, Inc. | 2019-01-16 |
| T2 STRATOSPHERE Expandable Corpectomy System (K183510) | Medtronic Sofamor Danek USA, Inc. | 2019-01-16 |
| 4CIS® Pinehurst Anterior Cervical Plate system (K182489) | Solco Biomedical Co., Ltd. | 2019-01-16 |
| Carestream DRX-1 System with DRX Core Detectors (K183474) | Carestream Health, Inc. | 2019-01-16 |
| URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R (K181451) | Olympus Medical Systems Corp. | 2019-01-16 |
| Dosis SAM (K180410) | Dosis, Inc. | 2019-01-16 |
| Estremo Citieffe Nailing System (K181540) | Citieffe S.R.L. | 2019-01-16 |
| SIRA RFA Electrosurgical Device (K181071) | Innoblative Designs, Inc. | 2019-01-16 |
| Pristine Scope (K183165) | Pristine Surgical | 2019-01-16 |
| Disposable Ultra Reinforced Surgical Gown (K173847) | Xiantao Rayxin Medical Products Co., Ltd. | 2019-01-16 |
| Laser Hair Therapy (K183329) | Omm Imports, Inc. D/B/A Zero Gravity | 2019-01-16 |
| Avenue P Cage System (K181096) | Zimmer Biomet Spine, Inc. | 2019-01-15 |
| OsteoCool RF Ablation System (K182497) | Medtronic Sofamor Danek USA, Inc. | 2019-01-15 |
| JUSHA-M260G LCD Monitor, JUSHA-M260 LCD Monitor, M260G LCD Monitor, M260 LCD Monitor (K183497) | Nanjing Jusha Display Technology Co., Ltd. | 2019-01-15 |
| Whistler Modular Pedicle Screw System (K182478) | Evolution Spine, LLC | 2019-01-15 |
| Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing) (K180570) | Argentum Medical, LLC | 2019-01-14 |
| ZELTIQ CoolSculpting System (K183514) | Zeltiq Aesthetics, Inc. | 2019-01-14 |
| TenoTac Soft Tissue Fixation System (K182898) | Paragon 28, Inc. | 2019-01-14 |
| Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System (K182307) | Paragon 28, Inc. | 2019-01-14 |
| MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly (K180902) | Medipines Corporation | 2019-01-11 |
| Senhance Ultrasonic System (K182421) | Transenterix, Inc. | 2019-01-11 |
| Tamper Evident Cap with Male Luer Lock (K182545) | International Medical Industries, Inc. | 2019-01-11 |
| SLEEPAPP (K182202) | Comfort Acrylics, Inc. | 2019-01-11 |
| Roadrunner Extra Support Wire Guide (K183467) | Cook Incorporated | 2019-01-11 |
| uMR 580, uMR 588 (K183137) | Shanghai United Imaging Healthcare Co., Ltd. | 2019-01-11 |
| MULTIX Impact (K182517) | Siemens Medi Cal Solutions, Inc. | 2019-01-11 |
| Catalyst CSR Press-Fit Humeral Components (K182500) | Catalyst Orthoscience, Inc. | 2019-01-11 |
| CD Horizon™ Spinal System (K182928) | Medtronic Sofamor Danek USA, Inc. | 2019-01-11 |
| ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER) (K182453) | I-Tech Industries Srl | 2019-01-11 |
| PROSTEP MICA Screw System (K181377) | Wrightmedicaltechnologyinc | 2019-01-11 |
| ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL) (K183031) | Biomerieux S.A. | 2019-01-11 |
| CereLink ICP Monitor, CereLink ICP Extension Cable (K183406) | Integra Lifesciences Corp. | 2019-01-11 |
| II-Type Intervertebral Spacer (K180228) | Paonan Biotech Co., Ltd. | 2019-01-11 |
| MTA2.3 MATERIALS (K181917) | NuSmile, Ltd. | 2019-01-11 |
| DigitalDiagnost C90 (K182973) | Philips Medical Systems Dmc GmbH | 2019-01-11 |
| Geo Staple System (K182212) | Gramercy Extremity Orthopedics, LLC | 2019-01-11 |
| Applied Tissue Technologies PWD™ Platform Wound Dressing (K182409) | Applied Tissue Technologies, LLC | 2019-01-11 |
| UV Phototherapy (K181805) | Xuzhou Kernel Medical Equipment Co., Ltd. | 2019-01-11 |
| MTS Tetracycline 0.016 - 256 ug/mL (K183140) | Liofilchem s.r.l. | 2019-01-11 |
| AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) (K181649) | Trudell Medical International | 2019-01-11 |
| RESCAN 700, CALLISTO eye (K180229) | Carl Zeiss Meditec, AG | 2019-01-11 |
| STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices (K182873) | ETHICON, Inc. | 2019-01-10 |
| Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream (K183097) | Weihai Kangzhou Biotechnology Engineering Co., Ltd. | 2019-01-10 |
| Maxpower Relief (K182120) | Omron Healthcare, Inc. | 2019-01-10 |
| RENASYS Y-Connector; RENASYS TOUCH (K181204) | Smith & Nephew Medical Limited | 2019-01-10 |
| DIASAFEplusUS (K182367) | Fresenius Medical Care Renal Therapies Group, LLC | 2019-01-10 |
| VLIFT-s Vertebral Body Replacement System (K183071) | Stryker Spine | 2019-01-10 |
| Additive Orthopaedics Patient Specific 3D Locking Lattice Plates (K183011) | Additive Orthopaedics | 2019-01-10 |
| HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) (K183616) | M.I.Tech Co., Ltd. | 2019-01-10 |
| Signal Catheter (K182635) | Safe Medical Design | 2019-01-10 |
| CONTEC Oxygen Concentrator (K180837) | Contec Medical System Co., Ltd. | 2019-01-10 |
| DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System (K182636) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019-01-10 |
| Trident HD Specimen Radiography System (K182727) | Hologic, Inc. | 2019-01-10 |
| Infrared Ear Thermometer (K180387) | Hetaida Technology Co., Ltd. | 2019-01-10 |
| OSSIO™ Pin Product Family (K181180) | OSSIO , Ltd. | 2019-01-10 |
| Advocate Non-Contact Infrared Thermometer (K180355) | Broadmaster Biotech, Corp. | 2019-01-10 |
| CLARUS (K181444) | Carl Zeiss Meditec, Inc. | 2019-01-10 |
| PENTAX Medical EPK-3000 Video Imaging System (K182846) | Pentax of America, Inc. | 2019-01-09 |
| Cortical Fixation Systems (K181086) | Cousin Biotech Sas | 2019-01-09 |
| iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses (K183200) | C&E GP Specialist, Inc. | 2019-01-09 |
| Wireless Digital Flat Panel Detector (K183422) | Iray Technology Taicang , Ltd. | 2019-01-09 |
| Wireless Digital Flat Detector (K183713) | Iray Technology Taicang , Ltd. | 2019-01-09 |
| G3A 40 Bone Cement (K181282) | G21, S.R.L. | 2019-01-09 |
| Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested for Use with Chemotherapy Drugs (K181047) | Smart Glove Corporation Sdn. Bhd. | 2019-01-09 |
| Fit SA (K182869) | Shofu Dental Corporation | 2019-01-09 |
| MRCP+ v1.0 (K183133) | Perspectum Diagnostics, Ltd. | 2019-01-09 |
| Reliance Lumbar IBF System (K181118) | Reliance Medical Systems | 2019-01-09 |
| DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System (K181637) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019-01-09 |
| INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor (K182868) | Covidien, LLC | 2019-01-08 |
| HS30 Diagnostic Ultrasound System (K182632) | Samsung Medison Co., Ltd. | 2019-01-08 |
| Omnipod Insulin Management System, Omnipod DASH Insulin Management System (K182630) | Insulet Corporation | 2019-01-08 |
| Park Dental Research Aligners (K180648) | Park Dental Research Corporation | 2019-01-08 |
| TruShot with Y-Knot Shallow All-Suture Anchor (K182439) | Conmed Corporation | 2019-01-08 |
| Choice Spine Navigation System (K182721) | Choicespine, LP | 2019-01-08 |
| BD MAX CTGCTV2, BD MAX System (K182692) | Becton, Dickinson and Company | 2019-01-08 |
| Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases (K180564) | Medentika GmbH | 2019-01-07 |
| FlareHawk Interbody Fusion System (K182114) | Integrity Implants, Inc. | 2019-01-07 |
| Precision Ideal Eyes Arthroscopes (K183470) | Stryker | 2019-01-07 |
| TiWAVE-L Porous Titanium Lumbar Cage (K182210) | Kalitec Medical, LLC | 2019-01-07 |
| Stryker Facial iD Plating System (K182305) | Stryker | 2019-01-07 |
| Care Orchestrator (K181053) | Respironics, Inc. | 2019-01-04 |
| BostonSight Scleral (K183175) | Bostonsight | 2019-01-04 |
| VERIFY VH202 Indicator Tape (K183293) | STERIS Corporation | 2019-01-04 |
| Rapid-i™ Kit (K181461) | Vitrolife Sweden AB | 2019-01-04 |
| BIO-C TEMP (K180199) | Angelus Industria DE Produtos Odontologicos S/A | 2019-01-04 |
| Polygon Resection Device (K182675) | Polygon Medical, Inc. | 2019-01-04 |
| GlideScope BFlex Single-Use Bronchoscope System (K183256) | Verathon Medical (Canada) Ulc | 2019-01-04 |
| Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml (K183033) | Thermo Fisher Scientific | 2019-01-04 |
| CrossFT Knotless Deep Thread Suture Anchor with Disposable Driver (K182621) | Conmed Corporation | 2019-01-04 |
| Celerity HP Chemical Indicator (CI) (K183295) | Steris Corporations | 2019-01-04 |
| PicoLO Nd:YAG Picosecond Laser System (K183392) | Laseroptek Co., Ltd. | 2019-01-04 |
| BridalVeil Navigated Instruments (K182982) | Astura Medical | 2019-01-04 |
| Straumann PURE Ceramic Implant System (K180477) | Institut Straumann AG | 2019-01-04 |
| SculpSure (K182741) | Cynosure | 2019-01-03 |
| Responsive Arthroscopy Suture Anchor System (K180951) | Responsive Arthroscopy, LLC | 2019-01-03 |
| V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System (K182568) | STERIS Corporation | 2019-01-03 |
| PRO-LITE Sterilization Tray (K183301) | STERIS Corporation | 2019-01-03 |
| Arm Blood Pressure Monitor (K180435) | Alicn Medical (Shenzhen), Inc. | 2019-01-03 |
| Safe Secure Sterilization Pouches and Rolls (K180139) | Safe Secure Packing Co., Ltd. | 2019-01-03 |
| Cufitec Surgical Mask (K182766) | Nbc Meshtec, Inc. | 2019-01-03 |