510(k) Clearances in 2017 — Page 40

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 40 of 64)
510(k) clearancesDetails
K163140 — SPINEL 12HD Interventional Fluoroscopic Mobile X-ray SystemGemss Medical Systems Co., Ltd. May 26, 2017
K171217 — DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction SystemOsprey Medical, Inc. May 26, 2017
K171059 — Nova StatSensor Creatinine Hospital Meter SystemNova Biomedical Corporation May 26, 2017
K171230 — My Dose CoachSanofi May 26, 2017
K170486 — CATHTONG II PICC CatheterL&Z Us, Inc. May 25, 2017
K171253 — Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing LeadMedtronic May 25, 2017
K171170 — M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A. May 25, 2017
K170557 — GenePOC GBS LBGenepoc, Inc. May 25, 2017
K170558 — revogeneGenepoc, Inc. May 25, 2017
K170892 — Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 µg/mLLiofilchem S.R.L. May 25, 2017
K170597 — PicoWay Laser SystemSyneron Candela Corporation May 25, 2017
K170944 — LCD Monitor (MD310C, MD310G, MD210G)Benq Corporation May 25, 2017
K170259 — TruAbutment DSTruabutment May 25, 2017
K170611 — SETx Pedicle Screw SystemXenco Medical, LLC May 25, 2017
K171238 — KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. May 25, 2017
K170242 — MultiGen™ 2 RF Generator SystemStryker Corporation May 25, 2017
K163196 — ACTION II Laser SystemLutronic Corporation May 24, 2017
K170172 — UNiD Spine AnalyzerMedicrea International May 24, 2017
K170603 — Tao Brush I.U.M.C. Endometrial SamplerCook Incorporated May 24, 2017
K171194 — AS-10, CXDI-401RFCanon, Inc. May 24, 2017
K170287 — Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH May 24, 2017
K163618 — INDIGO Aspiration SystemPenumbra, Inc. May 24, 2017
K163071 — vascuCAPElucid Bioimaging, Inc. May 24, 2017
K163257 — VitreOx Anti-fog SolutionSio2 Nanotech, LLC May 24, 2017
K162463 — Matrix Data Management SystemGlobal Instrumentation, LLC May 24, 2017
K162433 — GCE Zen-O Portable Oxygen ConcentratorOxus, Inc. May 24, 2017
K162409 — Gems Vitrification Set, Gems Warming SetGenea Biomedx Pty, Ltd. May 24, 2017
K170779 — Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable proteinTerang Nusa Sdn Bhd May 24, 2017
K163244 — truFreeze SystemCSA Medical, Inc. May 24, 2017
K170514 — Central Monitoring SystemGuangdong Biolight Meditech Co., Ltd. May 24, 2017
K163197 — Cook Holmium Laser FiberCook Incorporated May 24, 2017
K170306 — FIBERGRAFT BG Putty Bone Graft SubstituteProsidyan, Inc. May 24, 2017
K170891 — Mako Partial Knee ApplicationMako Surgical Corp. May 24, 2017
K170290 — Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo drShen Wei USA, Inc. May 24, 2017
K163172 — HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer KitSmiths Medical Asd, Inc. May 24, 2017
K170349 — RA-308 Excimer Laser System, Excimer Laser CatheterRa Medical Systems,Inc May 24, 2017
K163658 — ADVIA Centaur Intact Parathyroid Hormone (PTH) AssaySiemens Healthcare Diagnostics, Inc. May 23, 2017
K161833 — LATEX EXAMINATION GLOVE POWDER FREECareglove Global Sdn. Bhd. May 23, 2017
K162598 — HAPI SealBisco, Inc. May 23, 2017
K163430 — Prontosan Wound GelB.Braun Medical, Inc. May 23, 2017
K170489 — Skylit Phototherapy SystemSkylit Medical May 23, 2017
K163673 — Fortilink™-C with TETRAfuse™ 3D TechnologyRti Surgical, Inc. May 23, 2017
K163090 — Plasma Edge SystemChirurgie Innovation May 23, 2017
K170021 — SMV Scientific Cannulated ScrewsSmv Scientific May 22, 2017
K170586 — Strep B Carrot Broth One-StepHardy Diagnostics May 22, 2017
K163553 — Powder Free Nitrile Patient Examination Gloves, BlueHebei Titans Medical Supply Technology Group., Ltd. May 22, 2017
K171348 — Pinpoint GT Needle Guide KitsC.R. Bard, Inc. May 22, 2017
K170282 — Smith & Nephew VISIONAIRE Adaptive GuidesSmith & Nephew, Inc. May 22, 2017
K170121 — Lumenis Family of Holmium Surgical Lasers and Delivery Devices and AccessoriesLumenis, Ltd. May 22, 2017
K161689 — OSSTEM Implant System - AbutmentOsstem Implant Co., Ltd. May 22, 2017
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