| Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker (K162929) | Stryker Corporation | 2017-02-22 |
| MEG-TORQ (K161500) | Micro-Nx Co., Ltd. | 2017-02-22 |
| ND YAG Q-switch Laser Therapy Machine (K161926) | Beijing Adss Development Co., Ltd. | 2017-02-22 |
| Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 µg/mL (K163298) | Liofilchem s.r.l. | 2017-02-22 |
| Aquarius 8600 (K170202) | Imaging Dynamics Company , Ltd. | 2017-02-22 |
| PROPHECY INVISION Preoperative Navigation Alignment System (K162795) | Wrightmedicaltechnologyinc | 2017-02-22 |
| BLUEPRINT Patient Specific Instrumentation (K162800) | Tornier S.A.S. | 2017-02-22 |
| Sofia RSV FIA on Sofia 2 analyzer (K162911) | Quidel Corporation | 2017-02-22 |
| Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E (K163041) | Pt. Medisafe Technologies | 2017-02-22 |
| EasyOne Pro Respiratory Analysis System (K161534) | Ndd Medizintechnik AG | 2017-02-22 |
| Omron HEM-6400T-Z Wrist Blood Pressure Monitor (K163045) | Omron Healthcare, Inc. | 2017-02-21 |
| SMR TT Metal Back Glenoid, Bone Graft instruments (K161120) | Lima Corporate S.P.A. | 2017-02-21 |
| SpeedLyser Infusion Catheter Kit (K170258) | AngioDynamics, Inc. | 2017-02-21 |
| ELECTROmatic (K163317) | Kaltenbach & Voigt Gmgh | 2017-02-21 |
| AlignMATE™ Lapidus Arthrodesis System (K162391) | Arthrosurface, Inc. | 2017-02-21 |
| VariAx Distal Radius Plating System, VariAx 2 System (K162841) | Stryker GmbH | 2017-02-21 |
| ClearLumen II Peripheral Thrombectomy System (K163051) | Walk Vascular, LLC | 2017-02-21 |
| SurgTech Trauma System (K161894) | Surgtech, Inc. | 2017-02-21 |
| VibraPEP (K163091) | Medica Holdings, LLC | 2017-02-21 |
| TRU Legionella (K163273) | Meridian Bioscience, Inc. | 2017-02-21 |
| Arrowhead Mini-Rail Fixator (K162032) | Arrowhead De, LLC | 2017-02-21 |
| UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure (K161987) | Dio Corporation | 2017-02-21 |
| AXIOS Stent and Electrocautery Enhanced Delivery System (K163272) | Boston Scientific Corporation | 2017-02-18 |
| VIA 17 Microcatheter (K162565) | Sequent Medical, Inc. | 2017-02-18 |
| ExpressBraid Graft Manipulation (K163651) | Biomet Manufacturing Corp | 2017-02-17 |
| Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set (K160200) | Cook Incorporated | 2017-02-17 |
| GenNarino (K160799) | Saliwell , Ltd. | 2017-02-17 |
| Intra medullary endo-transilluminating device (iMET device) (K163037) | WeMED Bio-Tech, Inc. | 2017-02-17 |
| SeptiCyte LAB (K163260) | Immunexpress, Inc. | 2017-02-17 |
| CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) (K162281) | Sebia | 2017-02-17 |
| Sentry IVC filter (K162875) | Novate Medical , Ltd. | 2017-02-17 |
| ReDe Mask (K161953) | Tereopneuma | 2017-02-17 |
| Z-Span Plate System (K162824) | Zavation, LLC | 2017-02-17 |
| Care Cycle Connect Application (K161411) | Respironics, Inc. | 2017-02-17 |
| Companion (DEN140033) | Lgch, Inc. | 2017-02-16 |
| Spine Wave Anterior Cervical Spine System (K162760) | Spine Wave, Inc. | 2017-02-16 |
| T-Cuff (K162365) | Terumobct, Inc. | 2017-02-16 |
| ALLY™ Facet Screws (K163374) | Providence Medical Technology, Inc. | 2017-02-16 |
| VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL) (K161437) | bioMerieux, Inc. | 2017-02-16 |
| ClotTriever Thrombectomy System (K163549) | Inari Medical, Inc. | 2017-02-16 |
| DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw (K161616) | Synthes USA Products, LLC | 2017-02-16 |
| Kepler I Cervical Plate System (K163602) | Orbbo Surgical, LLC | 2017-02-16 |
| VitriGuard (K162833) | Origio A/S | 2017-02-16 |
| SLIT LAMP, Model: YF-100 (K161764) | Chongqing Yeasn Science-Technology Co., Ltd. | 2017-02-16 |
| RF1400 Active Compression Wrap (K162481) | Recovery Force, LLC | 2017-02-16 |
| Valleylab FT10 Electrosurgical Platform (K170170) | Covidien, LLC | 2017-02-16 |
| Laparoscope Lens Shield Device (LENS) (K170103) | Medeon Biodesign, Inc. | 2017-02-16 |
| Fiagon Navigation – PointerTube Straight and PointerTube Keat (K163416) | Fiagon GmbH | 2017-02-16 |
| AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System (K153561) | Andon Health Co, Ltd. | 2017-02-16 |
| STERRAD NX Sterilizer (K162007) | Advanced Sterilization Products | 2017-02-16 |
| Huvex Interspinous Fixation System (K162849) | Dio Medical Co., Ltd. | 2017-02-16 |
| SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction (K162965) | Tei Biosciences, Inc. | 2017-02-16 |
| AM-100 (K163165) | BTL Industries, Inc. | 2017-02-16 |
| Miromatrix Biological Mesh TW (K162570) | Miromatrix Medical, Inc. | 2017-02-16 |
| 4CIS® Marlin ACIF Cage System (K162402) | Solco Biomedical Co., Ltd. | 2017-02-16 |
| 0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE (K161996) | Amend Surgical, Inc. | 2017-02-16 |
| TAP Blood Collection Device (K161521) | Seventh Sense Biosystems, Inc. | 2017-02-16 |
| IBS Implant System II (K162099) | Innobiosurg Co., Ltd. | 2017-02-15 |
| PC ECG (K160876) | Edan Instruments, Inc. | 2017-02-15 |
| Abbott ARCHITECT Free T3 (K170160) | Abbott Laboratories | 2017-02-15 |
| Medela Low Dose Enteral Syringe (K161811) | Medela, Inc. | 2017-02-15 |
| Erisma® LP Spinal Fixation System (K170163) | Clariance, Sas | 2017-02-14 |
| ENSEAL X1 Large Jaw Tissue Sealer (K163548) | Ethicon Endo-Surgery, LLC | 2017-02-14 |
| Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack (K163085) | Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC | 2017-02-14 |
| Bashan TDP Heat Lamp (K162590) | Chogqing Yuhe Medical Instruments Co., Ltd. | 2017-02-14 |
| SIGNA PET/MR (K163619) | Ge Medical Systems, LLC | 2017-02-14 |
| syngo Application Software (K163285) | Siemens Medical Solution USA, Inc. | 2017-02-14 |
| Fully Automatic Electronic Blood Pressure Monitor (K162668) | Andon Health Co, Ltd. | 2017-02-14 |
| ClariFix Device (K162608) | Arrinex, Inc. | 2017-02-14 |
| SIS Software (K162830) | Surgical Information Sciences, Inc. | 2017-02-14 |
| FilmArray NGDS Warrior Panel (DEN160048) | Biofire Defense, LLC | 2017-02-14 |
| Reveal LINQ Insertable Cardiac Monitor (K163460) | Medtronic, Inc. | 2017-02-14 |
| FA100 SCCD (Sequential Continuous Contraction Device) (K162987) | Flowaid Medical Technologies, Corp | 2017-02-14 |
| VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL) (K161510) | bioMerieux, Inc. | 2017-02-13 |
| KerraCel Ag Gelling Fiber Silver Dressing (K162508) | Exciton Technologies, Inc. | 2017-02-13 |
| Ultima HA Coated Half Pins and Wire (K163487) | Vilex IN Tennessee, Inc. | 2017-02-13 |
| Serranator Alto PTA Serration Balloon Catheter (K163380) | Cagent Vascular, LLC | 2017-02-13 |
| Advance 14LP Low Profile PTA Balloon Dilatation Catheter (K170193) | Cook Incorporated | 2017-02-13 |
| MCS Bone Graft (K162860) | Bioventus, LLC | 2017-02-13 |
| POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs (K163146) | Hebei Hongsen Plastics Technology Co, Ltd. | 2017-02-13 |
| Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System (K162456) | Cepheid | 2017-02-13 |
| Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set (K160610) | Kobold, LLC | 2017-02-13 |
| JUVORA Dental Disc, Ceramill PEEK by JUVORA (K160918) | Juvora | 2017-02-13 |
| Blood Pressure Monitor (K162089) | Beijing Choice Electronic Technology Co., Ltd. | 2017-02-10 |
| Revision Femoral Stem (K161226) | Lima Corporate S.P.A. | 2017-02-10 |
| XSmart iQ (K161213) | Dentsply Sirona | 2017-02-10 |
| SteriTite Containers System & MediTray Products (K161415) | Case Medical, Inc. | 2017-02-10 |
| GORE BIO-A Tissue Reinforcement (K163217) | W. L. Gore & Associates, Inc. | 2017-02-10 |
| CRYLREX (K161629) | Sm Eng Co., Ltd. | 2017-02-10 |
| Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH (K161606) | Terumo Europe N.V. | 2017-02-10 |
| EasyClip Xpress (K162321) | Restore Surgical, LLC Dba Instratek | 2017-02-10 |
| Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal (K162697) | Custom Orthopaedic Solutions, Inc. | 2017-02-10 |
| Astroglide Diamond Silicone Gel Personal Lubricant (K163395) | Biofilm, Inc. | 2017-02-10 |
| MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System) (K162774) | Medtronic, Inc. | 2017-02-10 |
| LOGIQ P9 and LOGIQ P7 (K163596) | GE Healthcare | 2017-02-10 |
| UA-Cellular Complete (K170091) | Streck | 2017-02-09 |
| Atlas Spine Expandable Interbody System (K162918) | Atlas Spine, Inc. | 2017-02-09 |
| Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System (K162331) | Cepheid | 2017-02-09 |
| Low Profile Balloon Feeding Device (K161413) | Applied Medical Technology, Inc. | 2017-02-09 |
| Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload (K162710) | Tgs Medical Co., Ltd. | 2017-02-09 |