510(k) Clearances in 2017 — Page 32

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 32 of 64)
510(k) clearancesDetails
K163137 — NIRA Beauty Skin LaserDermal Photonics Corporation Jul 12, 2017
K171800 — OEC Elite MiniViewGe Hualun Medical Systems Co. , Ltd. Jul 12, 2017
K171780 — OrthAlign Plus SystemOrthalign, Inc. Jul 11, 2017
K171401 — ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1Elitechgroup Jul 11, 2017
K163406 — Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring SystemACON Laboratories, Inc. Jul 11, 2017
K171316 — O2Vent WOventus Manufacturing Pty, Ltd. Jul 11, 2017
K162881 — Kitazato OPU NeedlesKitazato Corporation Jul 11, 2017
K163353 — Needle's Eye Snare Retrieval Set - 54cmCook Incorporated Jul 11, 2017
K171133 — Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and AccessoriesQfix Jul 11, 2017
K170814 — Devon 24Devon Medical Products (Jiangsu), Ltd. Jul 11, 2017
K171000 — P60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp. Jul 11, 2017
K170503 — EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF CagesEit Emerging Implant Technologies GmbH Jul 11, 2017
K171105 — AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine Jul 11, 2017
K171908 — 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing3M Company Jul 11, 2017
K162470 — RT300 FES cycle ergometerRestorative Therapies, Inc. Jul 11, 2017
K171078 — TRI-COMBO PARASITE SCREENTechlab, Inc. Jul 10, 2017
K171092 — XiniWave II Model ECS322PInternational Trade Group, Inc. Jul 10, 2017
K162934 — Biodesign Parastomal Hernia Repair GraftCook Biotech Incorporated Jul 10, 2017
K171034 — M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, M8 Elite Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. Jul 10, 2017
K170768 — Mini NeedleOcuject, LLC Jul 10, 2017
K170397 — Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy DrugsKossan International Sdn Bhd Jul 10, 2017
K160337 — Safecare Open Back Protective Gowns and ValueCare Open Back Protective GownsBam Corporation Limited Jul 7, 2017
K170941 — RX NC Takeru PTCA Balloon Dilatation CatheterKANEKA Corporation Jul 7, 2017
K163035 — DilaCheck Nitrile Powder Free Examination Glove, (Sterile)Elm Tree Medical, Inc. Jul 7, 2017
K171046 — SeaSpine Cambria SystemSeaSpine Orthopedics Corporation Jul 7, 2017
K170480 — Models 3543A, 4343A, 2929A and A843BShanghai PZ Medical Technolgoy Co., Ltd. Jul 7, 2017
K171448 — Hammertoe Correction SystemLife Spine, Inc. Jul 7, 2017
K171087 — AXON IR Heat LampCrystal Medtech, LLC Jul 7, 2017
K163648 — Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 SeriesGrandway Technology (Shenzhen) Limited Jul 7, 2017
K163584 — M3290B Philips IntelliVue Information Center iXPhilips Medical Systems Jul 7, 2017
K171454 — Interject Injection Therapy Needle CatheterBoston Scientific Corporation Jul 7, 2017
K171711 — Thunder, Thunder VT, Thunder HRQuanta System Spa Jul 7, 2017
K171461 — SkyPlate Detector for Philips Radiography/Fluoroscopy SystemsPhilips Medical Systems Dmc GmbH Jul 7, 2017
K170541 — Anorganic Bone Mineral in Delivery ApplicatorCollagen Matrix, Inc. Jul 7, 2017
K162992 — Karl Storz UROMAT E.A.S.I.Karl Storz Endoscopy America, Inc. Jul 7, 2017
K171339 — EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy DrugsEco Medi Glove Sdn. Bhd. Jul 7, 2017
K171069 — ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. Jul 7, 2017
K161349 — Everyway Incontinence Stimulation SystemEveryway Medical Instrument Co., Ltd. Jul 7, 2017
K171698 — Smart SyringeOsprey Medical, Inc. Jul 7, 2017
K162398 — CO2 Laser Therapy SystemsBeijing Sincoheren Science And Technology Development Co. Jul 6, 2017
K171055 — Philips BlueControlPhilips Electronics Nederland B.V. Jul 6, 2017
K171031 — CRESCENT™ Spinal SystemMedtronic Sofamor Danek Jul 6, 2017
K162190 — Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)Villa Sistemi Medicali S.P.A. Jul 6, 2017
K161394 — HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega LuxSportarredo Group S.C. Jul 6, 2017
K170224 — Spider Cervical Plating SystemX-Spine Systems, Inc. Jul 6, 2017
K170399 — Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC Jul 6, 2017
K170143 — GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B,Bionime Corporation Jul 6, 2017
K170587 — On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for UrinalysisACON Laboratories, Inc. Jul 6, 2017
K171398 — Dermal Cooling SystemR2 Dermatology ,Inc Jul 6, 2017
K162609 — ClearPath AlignerClearpath Orthodontics, Ltd. Jul 6, 2017
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