| PRECICE System (K172628) | Nuvasive Specialized Orthopedics, Inc. | 2017-09-25 |
| Urbanek Device (K170985) | Tmj Services, LLC | 2017-09-25 |
| GALAXY G3 Mini Microcoil Delivery System (K171862) | Codman & Shurtleff, Inc. | 2017-09-25 |
| Dimensional Bioceramics Calcium Sulfate Device (DB-CSD) (K171161) | Dimensional Bioceramics, LLC | 2017-09-25 |
| Xpert Xpress Strep A (K172126) | Cepheid | 2017-09-25 |
| LapBag (K171726) | Sejong Medical Co., Ltd. | 2017-09-25 |
| INDEPENDENCE® Spacers (K170157) | Globus Medical, Inc. | 2017-09-25 |
| Powder-free Clear Vinyl Patient Examination Gloves (K171460) | Shandong Zhiwei Medical Products, Co. , Ltd. | 2017-09-24 |
| Thermage FLX System and Accessories (K170758) | Solta Medical | 2017-09-22 |
| Sterling Supreme Diode Laser (K171986) | CAO Group, Inc. | 2017-09-22 |
| ULTRASCORE Focused Force PTA Balloon (K172571) | C. R. Bard | 2017-09-22 |
| Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera, Exsens Personal Lubricant - Fresh Mint, Exsens Personal Lubricant - Candy Apple, Exsens Personal Lubricant - Raspberry (K163674) | Neo Cosmetique | 2017-09-22 |
| Matira™ Anterior Cervical System (K172086) | Kalitec Direct, LLC | 2017-09-22 |
| Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664 (K171303) | University of Texas Medical School AT Houston, Texas | 2017-09-22 |
| NOWCARDIO SYSTEM (K162956) | Contex International Technologies (Canada), Inc. | 2017-09-22 |
| SERI Contour (K172545) | Sofregen Medical, Inc. | 2017-09-22 |
| TempSure (K171262) | Cynosure, Inc. | 2017-09-22 |
| Straumann CARES Golden Ti/TiN Abutments (K162848) | Institut Straumann AG | 2017-09-22 |
| WiTouch Pro, WiTouch, Neubac (K171599) | Hollywog, LLC | 2017-09-22 |
| IV Fat Emulsion Administration Sets (K172544) | Baxter Healthcare Corporation | 2017-09-22 |
| Occlusion Detection Dressing Kit (K171499) | Cardinalhealth | 2017-09-22 |
| SYSTEM 1E Liquid Chemical Sterilant Processing System (K170956) | STERIS Corporation | 2017-09-22 |
| EndoNaut (K171829) | Therenva Sas | 2017-09-21 |
| ARIX Wrist System (K170705) | Jeil Medical Corporation | 2017-09-21 |
| Mako Total Knee Application (K172219) | Mako Surgical Corp. | 2017-09-21 |
| ZS3 Ultrasound System, z.one pro Ultrasound System (K171891) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2017-09-21 |
| Scanostics UTI Check Application Test System (K170118) | Teco Diagnostics | 2017-09-21 |
| Persyst Mobile App (K171184) | Persyst Development Corporation | 2017-09-21 |
| S60 Series Digital Color Doppler Ultrasound System (K172082) | Sonoscape Medical Corp. | 2017-09-21 |
| IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories (K170879) | Intuitive Surgical, Inc. | 2017-09-21 |
| PeriView FLEX (K171232) | Olympus Surgical Technologies America | 2017-09-21 |
| AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX (K163462) | Radiometer Medical Aps | 2017-09-21 |
| Zap-X Radiosurgery System (K171804) | Zap Surgical Systems | 2017-09-21 |
| Eztetic BellaTek Encode Healing Abutments (K170013) | Biomet 3i | 2017-09-21 |
| da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes (K170641) | Intuitive Surgical, Inc. | 2017-09-21 |
| DARCO Locking Bone Plate System (K171852) | Wrightmedicaltechnologyinc | 2017-09-21 |
| Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 120 mL cup, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 100mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 250mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 500mL bottle (K172486) | Anexa Biomedical, Inc. | 2017-09-21 |
| iNSitu Total Hip System (K172501) | Theken Companies, LLC | 2017-09-21 |
| Salter Labs Bubble Humidifier (K161719) | Salter Labs | 2017-09-21 |
| PMT Posterior Fixation System (K172279) | Providence Medical Technology, Inc. | 2017-09-20 |
| Magic3 Go Intermittent Urinary Catheter (K172247) | C.R. Bard, Inc. | 2017-09-20 |
| Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices (K172566) | Hologic, Inc. | 2017-09-20 |
| NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) (K171822) | Biotest Medical Corporation | 2017-09-20 |
| Ceramill Zolid HT+ white (K171876) | Amann Girrbach AG | 2017-09-20 |
| PENTAX Medical ED34-i10T, Video Duodenoscope (K163614) | Pentax Medical | 2017-09-20 |
| Tri-Ex Extraction Balloon With Multiple Sizing (K170292) | Wilson-Cook Medical, Inc. | 2017-09-20 |
| PICO Single Use Negative Pressure Wound Therapy System (K172521) | Smith & Nephew Medical Limited | 2017-09-20 |
| HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 (K163283) | Hamilton Medical AG | 2017-09-20 |
| Powder Free Nitrile Examination Gloves (Orange) (K171541) | Comfort Rubber Gloves Industries Sdn. Bhd. | 2017-09-20 |
| Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) (K172314) | Art Optical Contact Lens, Inc. | 2017-09-20 |
| Medline Blood Collection Set (K170002) | Medline Industries, Inc. | 2017-09-19 |
| da Vinci Xi Surgical System (K171632) | Intuitive Surgical, Inc. | 2017-09-19 |
| Finger Pulse Oximeter (K163135) | Shenzhen Fitfaith Technology Co.,Ltd | 2017-09-19 |
| Accordion Piccolo Stone Management Device (K172299) | Ths International, Inc. D/B/A Accordion Medical | 2017-09-19 |
| Digital Thermometer (K163518) | Joytech Healthcare Co. , Ltd. | 2017-09-19 |
| ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium (K172199) | Medtronic Sofamor Danek | 2017-09-19 |
| ECOM™ Cardiac Output Monitoring System (K172196) | Ecom Medical, Inc. | 2017-09-19 |
| LigaMetrics Suture Anchors (K171964) | Mortise Medical, LLC | 2017-09-19 |
| Pain Therapy Device (K163611) | Guangzhou Xinbo Electronic Co., Ltd. | 2017-09-19 |
| LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity (K170179) | Lumenis, Ltd. | 2017-09-18 |
| Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM, Largan (hioxifilcon A) Daily Wear Soft (Hydrophilic) Contact Lens for PRESBYOPIA (K170286) | Largan Medical Co., Ltd. | 2017-09-18 |
| Shanghai Sanyou PEEK Cage System (K163422) | Shanghai Sanyou Medical Co, Ltd. | 2017-09-18 |
| Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers (K172587) | Medacta International S.A. | 2017-09-18 |
| Health-e-Connect System with IDA (K163664) | Alr Technologies | 2017-09-18 |
| VITROS Chemistry Products GLU Slides (K163433) | Ortho Clinical Diagnostics | 2017-09-18 |
| Winback Back 3SE (K162828) | Winback USA Corp | 2017-09-18 |
| Endoscope Sterilization Tray (K170640) | Intuitive Surgical, Inc. | 2017-09-17 |
| BD Cathena Safety IV Catheter (K172506) | Becton, Dickinson and Company | 2017-09-17 |
| iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5) (K170231) | Andon Health Co, Ltd. | 2017-09-15 |
| Fresenius Liberty Select Cycler (K171652) | Fresenius Medical Care Renal Therapies Group, LLC | 2017-09-15 |
| Glidewire GT (K170417) | Terumo Corporation | 2017-09-15 |
| FLXfit™ (K171519) | Expanding Orthopedics, Inc. | 2017-09-15 |
| Phoenix Clinical ICON (K170527) | Phoenix Technology Group, Inc. Dba Phoenix Clinical | 2017-09-15 |
| Cefaly Acute (K171446) | Cefaly Technology | 2017-09-15 |
| Stryker Consolidated Operating Room Equipment (CORE) 2 Console (K171840) | Stryker Corporation | 2017-09-15 |
| Psychemedics Microplate EIA for Benzodiazepines in Hair (K163590) | Psychemedics Corporation | 2017-09-15 |
| Leksell Vantage Stereotactic System (K171123) | Elekta Instrument AB | 2017-09-15 |
| A.B. DENTAL DEVICES Dental Implants System (K162482) | A.B. Dental Device , Ltd. | 2017-09-15 |
| neuro inspire (K163666) | Rensihaw Plc | 2017-09-15 |
| Ti-Diagon Oblique TLIF (K172064) | Camber Spine Technologies | 2017-09-15 |
| Mazor X (K172522) | Mazor Robotics , Ltd. | 2017-09-15 |
| WowGoHealth Blood Glucose Monitoring System (K171785) | Biotest Medical Corporation | 2017-09-15 |
| BladderScan Prime PLUS System (K172356) | Verathon Incorporated | 2017-09-15 |
| Medentika CAD/CAM TiBases (K170838) | Medentika GmbH | 2017-09-15 |
| Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL) (K172150) | bioMerieux, Inc. | 2017-09-15 |
| Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System (K171686) | Choicespine | 2017-09-15 |
| PICO Single Use Negative Pressure Wound Therapy System (K172519) | Smith & Nephew Medical Limited | 2017-09-15 |
| M-CATH Microcatheter (K171176) | Acrostak (Schweiz) AG | 2017-09-15 |
| Veress Needle (K172120) | Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd | 2017-09-14 |
| Amsel Occluder Device (K172479) | Amsel Medical | 2017-09-14 |
| Bard Mission Disposable Core Biopsy Instrument (K171953) | Bard Peripheral Vascular, Inc. | 2017-09-14 |
| Masimo Rad-97 and Accessories (K170168) | Masimo Corporation | 2017-09-14 |
| reSet (DEN160018) | Pear Therapeutics, Inc. | 2017-09-14 |
| Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs (K171378) | Semperit Investments Asia Pte , Ltd. | 2017-09-14 |
| VIPER PRIME navigated inserter (K170937) | Medos International SARL | 2017-09-14 |
| Shotel Ankle Arthrodesis Nail System (K163627) | Biopro, Inc. | 2017-09-14 |
| AirLife Adult Heated Wire BiPAP/NIV Circuit (K170378) | Vyaire Medical | 2017-09-14 |
| Fiagon Navigation System (K163209) | Fiagon GmbH | 2017-09-14 |
| IntelliCart System (K172481) | Dornoch Medical Systems | 2017-09-14 |
| Entuit Start Initial Placement Gastrostomy Set (K170323) | Cook Incorporated | 2017-09-14 |