| ToeMATE® Hammertoe Correction System (K170350) | Arthrosurface, Inc. | 2017-03-03 |
| Curasite (K161991) | Izun Pharmaceuticals | 2017-03-03 |
| TheraView TBI (K170058) | Cablon Medical B.V. | 2017-03-03 |
| Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit; Linear Cutting Stapler and Single Use Loading Unit; Disposal Hemorrhoidal Circular Stapler (K162947) | Chongqing Qmi Surgical Co., Ltd. | 2017-03-03 |
| Inqwire Diagnostic Guide Wire (K163575) | Merit Medical Systems, Inc. | 2017-03-03 |
| DigiX FDX (K162529) | Allengers Medical Systems Limited | 2017-03-03 |
| HITACHI Supria Whole-body X-ray CT System Phase 3 (K163528) | Hitachi Medical Systems America, Inc. | 2017-03-03 |
| Guardian Angel GA1000 Digital Vital Sign Monitoring System (K162580) | Taiwan Aulisa Medical Devices Technologies, Inc. | 2017-03-03 |
| RayStation 6 (K170355) | RaySearch Laboratories AB (PUBL) | 2017-03-02 |
| Edi Catheter ENFit (K153688) | Maquet Critical Care AB | 2017-03-02 |
| MR Conditional CGA 870 (K162811) | Essex Industries, Inc. | 2017-03-02 |
| TIPCAM 1S 3D System (K162410) | Karl Storz Endoscopy America, Inc. | 2017-03-02 |
| Slimming Treatment Device (K161892) | Beijing Honkon Technologies Co., Ltd. | 2017-03-02 |
| n!ce Glass Ceramic Blocks for Amann Girrbach (K170420) | Institut Straumann AG | 2017-03-02 |
| Vesair Cystoscopic Sheath (K162356) | Solace Therapeutics | 2017-03-02 |
| Intellijoint HIP Generation 2A System (K162364) | Intellijoint Surgical, Inc. | 2017-03-02 |
| Myoject Luer Lock Needle Electrode (K161430) | Natus Manufacturing Limited | 2017-03-02 |
| EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture Bolt (K163497) | Encore Medical L.P. | 2017-03-02 |
| Signia Four-Bay Smart Charger (to be used with Signia Stapler) (K170348) | Covidien | 2017-03-02 |
| REXLON, REXSIL (K161633) | Sm Eng Co., Ltd. | 2017-03-02 |
| KneeAlign 2 System (K163379) | Orthalign, Inc. | 2017-03-02 |
| ENDOFLATOR 40, ENDOFLATOR 50 (K161554) | KARL STORZ Endoscopy-America, Inc. | 2017-03-02 |
| Dextramer CMV Kit (K153538) | Immudex Aps | 2017-03-02 |
| Cascade IOMAX Intraoperative Monitor (K162199) | Cadwell Industries, Inc. | 2017-03-02 |
| EndoPur Filter (K161304) | Nephros, Inc. | 2017-03-02 |
| RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed (K161737) | Myco Medical | 2017-03-02 |
| Cadwell Sierra Summit, Cadwell Sierra Ascent (K162383) | Cadwell Industries, Inc. | 2017-03-01 |
| DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESS (K170332) | Canon, Inc. | 2017-03-01 |
| syngo. CT Neuro Perfusion (K163284) | Siemens Medical Solutions USA, Inc. | 2017-03-01 |
| EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions (K162026) | Microport Orthopedics, Inc. | 2017-03-01 |
| BD Nexiva Diffusics Closed IV Catheter System (K170283) | Becton, Dickinson and Company | 2017-02-28 |
| EPIC Extremity Snap-Off Screw (K163038) | Epic Extremity, LLC | 2017-02-28 |
| Apex Dental Sensors (K163282) | Masterlink, LLC | 2017-02-28 |
| On1 Concept (K161655) | Nobel Biocare AB | 2017-02-28 |
| Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532™ Laser System (K162837) | Lumenis, Ltd. | 2017-02-28 |
| Virtual Occupational Therapy Application (VOTA) (K163245) | Barron Associates, Inc. | 2017-02-28 |
| Jac-Cell Medic testers (K170105) | Jac-Cell Medic | 2017-02-28 |
| RTC 26-C Inline Aerosol Adapter (K162753) | Instrumentation Industries, Inc. | 2017-02-28 |
| Surface Applicator Set (K162018) | Varian Medical Systems, Inc. | 2017-02-28 |
| CareLink SmartSync Device Manager - Pacing System Analyzer (K163008) | Medtronic, Inc. | 2017-02-28 |
| Biograph mMR with syngo MR E11P system software (K163234) | Siemens Medical Solutions USA, Inc. | 2017-02-28 |
| Biomet Fusion System (K163543) | Zimmer Biomet Spine, Inc. | 2017-02-28 |
| FIRMap Catheter (K163709) | Abbott Electrophysiology | 2017-02-28 |
| Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set (K170008) | Cook Incorporated | 2017-02-28 |
| proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System (K161853) | Aesculap, Inc. | 2017-02-27 |
| Kyphon Xpede Bone Cement (K163032) | Medtronic, Inc. | 2017-02-27 |
| Flextra Steerable Introducer (K170373) | Rhythm Xience, Inc. (Rxi) | 2017-02-27 |
| Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) (K162982) | Medline Industries, Inc. | 2017-02-27 |
| Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies (K162903) | Exactech, Inc. | 2017-02-27 |
| ComfortGuard Surgical Gown, i600, Film Reinforced (K163191) | Gri Medical & Electrical Technology Co., Ltd. | 2017-02-27 |
| BD PosiFlush Heparin Lock Flush Syringe (K163591) | Becton, Dickinson and Company | 2017-02-27 |
| Watch-PAT200U (K161579) | Itamar Medical , Ltd. | 2017-02-24 |
| HF 718BD X-Ray System (K160857) | Arquilla, Inc. Dba X-Cel X-Ray Corporation | 2017-02-24 |
| IllumiFlow Laser Cap (K162071) | Eglobal, LLC | 2017-02-24 |
| MagnetOs (K161859) | Xpand Biotechnology BV | 2017-02-24 |
| The ViewRay (MRIdian) Linac System (K162393) | Viewray, Incorporated | 2017-02-24 |
| DT-100 (K160358) | Mediana Co., Ltd. | 2017-02-24 |
| Sydney IVF Culture Oil (K170257) | William A. Cook Australia Pty. , Ltd. | 2017-02-24 |
| ZIIP Device (K161484) | Ziip,Llc | 2017-02-24 |
| The Red Head Collection Device, The Jordy Connection System (K161372) | Miami Fat Supply | 2017-02-24 |
| EkoSonic Endovascular System with Control Unit 4.0 (K162771) | Btg International, Inc. | 2017-02-24 |
| Renamel NANO +plus (K163480) | Cosmedent, Inc. | 2017-02-24 |
| Rusch Simplastic Foley Catheters (K162989) | Teleflexmedical, Inc. | 2017-02-24 |
| ARTIA Reconstructive Tissue Matrix Perforated (K162752) | Lifecell Corporation | 2017-02-24 |
| Arrow Endurance Extended Dwell Peripheral Catheter System (K163513) | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2017-02-24 |
| Dental Implants OKTAGON Tissue Level and Bone Level (K162073) | Hager& Meisinger GmbH | 2017-02-24 |
| Vesco Medical NRFit Tip Syringes (K170218) | Vesco Medical, LLC | 2017-02-24 |
| Revolution™ Spinal Fixation System (K163056) | Intelligent Implant Systems, LLC | 2017-02-24 |
| TG-970P CO2 Sensor Kit (K161860) | Nihon Kohden Corporation | 2017-02-24 |
| 3NT endoscopy system (K162916) | 3nt Medical , Ltd. | 2017-02-24 |
| Cercon (K162888) | Dentsply Sirona | 2017-02-24 |
| Sonoma Fifth Metatarsal Repair System (K161371) | Sonoma Orthopedic Products, Inc. | 2017-02-24 |
| Air-Powered Handpieces and Handpiece Attachments (K162926) | W&H Dentalwerk Burmoos GmbH | 2017-02-23 |
| VISULUX (K161607) | Carl Zeiss Meditec, AG | 2017-02-23 |
| Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow) (K163168) | Hebei Hongtai Plastic Products Company Limited | 2017-02-23 |
| George King Coumadin Plasma (K161316) | George King Bio-Medical, Inc. | 2017-02-23 |
| ImPACT (K170209) | Impact Applications, Inc. | 2017-02-23 |
| Family of Steam sterilizers B17 B22 Series (K161848) | Cefla S.C. | 2017-02-23 |
| VIDAS B.R.A.H.M.S. PCT (PCT) (K162827) | bioMerieux, Inc. | 2017-02-23 |
| GalaFORM 3D (K162922) | Tepha, Inc. | 2017-02-23 |
| Medtronic Transportation/Sterilization Cassettes (K163279) | Medtronic Sofamor Danek USA, Inc. | 2017-02-23 |
| Reveal LINQ (K162855) | Medtronic, Inc. | 2017-02-23 |
| Truliant Femoral Components (K170240) | Exactech, Inc. | 2017-02-23 |
| TZ SKULL PIN Adult (K163322) | Tz Medical, Inc. | 2017-02-23 |
| Lung Nodule Assessment and Comparison Option (LNA) (K162484) | Philips Medical Systems Nederland B.V. | 2017-02-23 |
| MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM (K160837) | Medinet Srl | 2017-02-23 |
| Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10 (K163688) | Medisono, LLC | 2017-02-23 |
| RSM 1824C with RConsole1 (K162670) | DRTECH Corporation | 2017-02-23 |
| Accelerate Pheno system, Accelerate Phenotest BC Kit (DEN160032) | Accelerate Diagnotics | 2017-02-23 |
| Pressure Therapy System (K161907) | Xiamen Senyang Co., Ltd. | 2017-02-23 |
| GRAVITYTM PEEK-OPTIMA Suture Anchor (K170265) | Wrightmedicaltechnologyinc | 2017-02-23 |
| Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis (K161693) | Stryker Sustainability Solutions | 2017-02-23 |
| Dual Top Screw System (K161335) | Jeil Medical Corporation | 2017-02-23 |
| Stryker OrthoMap Versatile Hip System (K162937) | Stryker Corporation | 2017-02-23 |
| Powder Free Nitrile Examination Gloves, Black (K161099) | Pt. Maja Agung Latexindo | 2017-02-23 |
| Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue) (K163126) | Blue Sail Medical Co.,Ltd | 2017-02-22 |
| my Patch sl (K163535) | Dms-Service, LLC | 2017-02-22 |
| HS70A Diagnostic Ultrasound System (K163691) | Samsung Medison Co., Ltd. | 2017-02-22 |
| BEMER Classic Set, BEMER Pro-Set (K151834) | Bemer Int AG | 2017-02-22 |
| SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™ Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Spacers, MONUMENT™ Spacers, ALTERA™ Spacers, MAGNIFY™ Spacers, InterContinental® Plate-Spacer (K152022) | Globus Medical, Inc. | 2017-02-22 |