510(k) Clearances in 2017 — Page 19

3,200 510(k) clearances total

Browse FDA 510(k) clearances granted in 2017. RegDataLab tracks 3,200 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2017 (page 19 of 64)
510(k) clearancesDetails
K170157 — INDEPENDENCE® SpacersGlobus Medical, Inc. Sep 25, 2017
K171726 — LapBagSejong Medical Co., Ltd. Sep 25, 2017
K172628 — PRECICE SystemNuvasive Specialized Orthopedics, Inc. Sep 25, 2017
K170985 — Urbanek DeviceTmj Services, LLC Sep 25, 2017
K172126 — Xpert Xpress Strep ACepheid Sep 25, 2017
K171943 — ElectrocardiographEdan Instruments, Inc. Sep 25, 2017
K163270 — ISEN-Goggles with Data ViewerIsent Tech & Trading Company, Ltd. Sep 25, 2017
K171460 — Powder-free Clear Vinyl Patient Examination GlovesShandong Zhiwei Medical Products, Co. , Ltd. Sep 24, 2017
K172545 — SERI ContourSofregen Medical, Inc. Sep 22, 2017
K162848 — Straumann CARES Golden Ti/TiN AbutmentsInstitut Straumann AG Sep 22, 2017
K170956 — SYSTEM 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation Sep 22, 2017
K170758 — Thermage FLX System and AccessoriesSolta Medical Sep 22, 2017
K171262 — TempSureCynosure, Inc. Sep 22, 2017
K172544 — IV Fat Emulsion Administration SetsBaxter Healthcare Corporation Sep 22, 2017
K162956 — NOWCARDIO SYSTEMContex International Technologies (Canada), Inc. Sep 22, 2017
K171599 — WiTouch Pro, WiTouch, NeubacHollywog, LLC Sep 22, 2017
K172086 — Matira™ Anterior Cervical SystemKalitec Direct, LLC Sep 22, 2017
K172571 — ULTRASCORE Focused Force PTA BalloonC. R. Bard Sep 22, 2017
K171499 — Occlusion Detection Dressing KitCardinalhealth Sep 22, 2017
K171303 — Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664University Of Texas Medical School AT Houston, Texas Sep 22, 2017
K171986 — Sterling Supreme Diode LaserCAO Group, Inc. Sep 22, 2017
K163674 — Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera, Exsens Personal Lubricant - Fresh Mint, Exsens Personal Lubricant - Candy Apple, Exsens Personal Lubricant - RaspberryNeo Cosmetique Sep 22, 2017
K172486 — 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 bottleAnexa Biomedical, Inc. Sep 21, 2017
K171184 — Persyst Mobile AppPersyst Development Corporation Sep 21, 2017
K170705 — ARIX Wrist SystemJeil Medical Corporation Sep 21, 2017
K172219 — Mako Total Knee ApplicationMako Surgical Corp. Sep 21, 2017
K170118 — Scanostics UTI Check Application Test SystemTeco Diagnostics Sep 21, 2017
K163462 — AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXRadiometer Medical Aps Sep 21, 2017
K172082 — S60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp. Sep 21, 2017
K171829 — EndoNautTherenva Sas Sep 21, 2017
K161719 — Salter Labs Bubble HumidifierSalter Labs Sep 21, 2017
K170879 — IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable AccessoriesIntuitive Surgical, Inc. Sep 21, 2017
K171891 — ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. Sep 21, 2017
K171232 — PeriView FLEXOlympus Surgical Technologies America Sep 21, 2017
K171852 — DARCO Locking Bone Plate SystemWrightmedicaltechnologyinc Sep 21, 2017
K172501 — iNSitu Total Hip SystemTheken Companies, LLC Sep 21, 2017
K170641 — da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesIntuitive Surgical, Inc. Sep 21, 2017
K170013 — Eztetic BellaTek Encode Healing AbutmentsBiomet 3I Sep 21, 2017
K171804 — Zap-X Radiosurgery SystemZap Surgical Systems Sep 21, 2017
K172314 — Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)Art Optical Contact Lens, Inc. Sep 20, 2017
K172521 — PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited Sep 20, 2017
K170292 — Tri-Ex Extraction Balloon With Multiple SizingWilson-Cook Medical, Inc. Sep 20, 2017
K172279 — PMT Posterior Fixation SystemProvidence Medical Technology, Inc. Sep 20, 2017
K163283 — HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010Hamilton Medical AG Sep 20, 2017
K172566 — Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesHologic, Inc. Sep 20, 2017
K171822 — NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352)Biotest Medical Corporation Sep 20, 2017
K171541 — Powder Free Nitrile Examination Gloves (Orange)Comfort Rubber Gloves Industries Sdn. Bhd. Sep 20, 2017
K163614 — PENTAX Medical ED34-i10T, Video DuodenoscopePentax Medical Sep 20, 2017
K171876 — Ceramill Zolid HT+ whiteAmann Girrbach AG Sep 20, 2017
K172247 — Magic3 Go Intermittent Urinary CatheterC.R. Bard, Inc. Sep 20, 2017
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