510(k) Clearances in 2017 — Page 42

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 42 of 64)
510(k) clearancesDetails
K171168 — VITROS Immunodiagnostic Products Insulin CalibratorsOrtho Clinical Diagnostics May 16, 2017
K163502 — iSR'obot Biopsy KitBiobot Surgical Pte., Ltd. May 16, 2017
K162133 — VerteFIT Corpectomy Cage SystemLdr Spine USA, Inc. May 16, 2017
K163701 — Direxion and Direxion HI-FLO Torqueable MicrocathetersBoston Scientific Corporation May 16, 2017
K170481 — Strep B Carrot Broth KitHardy Diagnostics May 16, 2017
K163226 — EPIC Extremely Small StapleEpic Extremely, LLC May 16, 2017
K170496 — Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation May 16, 2017
K171020 — Arthrex Knotless SutureTak AnchorArthrex, Inc. May 16, 2017
K170245 — DSM Biomedical Dental Bone GraftKensey Nash Corporation Dba Dsm Biomedical May 16, 2017
K170338 — A-ViewStroke2Prevent B.V. May 16, 2017
K170500 — SIROLaser Advance+Dentsply Sirona May 16, 2017
K170575 — Disposable Powder Free Vinyl Exam Glove, Clear/YellowEver Global (Vietnam) Enterprise Corp May 16, 2017
K163557 — SS SA FixtureOsstem Implant Co., Ltd. May 15, 2017
K170312 — IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting toolsMedtronic Powered Surgical Solutions May 15, 2017
K170784 — PNEUMOCLEARW.O.M. World Of Medicine GmbH May 15, 2017
K171137 — EVS 2430W, EVS 2430GWDRTECH Corporation May 15, 2017
K153410 — 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing3M Company May 15, 2017
K163638 — Dental 5 Multi Diode laserBio-Med USA, Inc. May 15, 2017
K170023 — SPiN Thoracic Navigation SystemVeran Medical Technologies, Inc. May 15, 2017
K170370 — ULTRASHAPE POWER SYSTEMSyneron Medical, Ltd. May 15, 2017
K162333 — Wondfo One Step Fecal Occult Blood (FOB) TestGuangzhou Wondfo Biotech Co., Ltd. May 14, 2017
K161261 — Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBaseGenea Biomedx Pty, Ltd. May 12, 2017
K170199 — Unity Network IDGE Healthcare May 12, 2017
K171072 — N Latex Cystatin C; N Protein Standard UYSiemens Healthcare Diagnostics Products GmbH May 12, 2017
K171119 — GM85Samsung Electronics Co., Ltd. May 12, 2017
K162392 — AvazziaAvazzia, Inc. May 12, 2017
K170401 — Piccolo Composite® Plate SystemCarboFix Orthopedics , Ltd. May 12, 2017
K170228 — Belimed Steam Sterilizer MST-H TOP 5000Belimed AG May 12, 2017
K171083 — iChemVELOCITY Automated Urine Chemistry SystemIris Diagnostics, A Division Of Iris International, Inc. May 12, 2017
K170648 — ANTHEM CR Total Knee SystemSmith & Nephew, Inc. May 11, 2017
K170647 — Connector SystemOrthofix, Inc. May 11, 2017
K170679 — CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® SystemsMedtronic Sofamor Danek May 11, 2017
K160667 — Anybattery C2 Rechargeable BatteryAnybattery, Inc. May 11, 2017
K170584 — Mako Partial Knee ApplicationMako Surgical Corp. May 11, 2017
K162328 — Winner Transfer WheelchairWinner SG Pte, Ltd. May 11, 2017
K170135 — TREFOIL SystemNobel Biocare AB May 11, 2017
K170205 — Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203Shenzhen Kentro Medical Electronics Co., Ltd. May 11, 2017
K170581 — Mako Total Knee ApplicationMako Surgical Corp. May 11, 2017
K161961 — UniTex Non-Sterile, Powder-Free, Latex Examination GloveUg Global Resources Sdn. Bhd. May 11, 2017
K161950 — Common Type Insulin Pen Needle, Safety Type Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. May 11, 2017
K162667 — Kitazato IUI CatheterKitazato Corporation May 11, 2017
K163276 — Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd. May 11, 2017
K162566 — AIK Sterile Acupuncture Needles for Single UseChangchun Aik Medical Devices Co., Ltd. May 11, 2017
K163576 — GORE SYNECOR Preperitoneal BiomaterialW. L. Gore & Associates, Inc. May 11, 2017
K170413 — BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control SetBio-Rad Laboratories May 11, 2017
K170382 — Arthrex Compression ScrewsArthrex, Inc. May 11, 2017
K163131 — A-dec NLZ Electric Motor SystemNakanishi, Inc. May 11, 2017
K170419 — SurgiCase ViewerMaterialise NV May 11, 2017
K170990 — Active Needle Endoscopic Treatment (ANET) Electrosurgical ApplicatorSpiration, Inc. May 11, 2017
K163622 — Lung VisionBodyvision Medical , Ltd. May 11, 2017
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