510(k) Clearances in 2018 — Page 57

3,062 510(k) clearances total

Browse FDA 510(k) clearances granted in 2018. RegDataLab tracks 3,062 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2018 (page 57 of 62)
510(k) clearancesDetails
K171516 — Flip LubeImquest Biosciences, Inc. Feb 5, 2018
K173849 — Triathlon Total Knee SystemStryker Orthopaedics Feb 2, 2018
K172005 — PICO 7 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited Feb 2, 2018
K171403 — OralTox Oral Fluid Drug TestPremier Biotech, Inc. Feb 2, 2018
K173981 — ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Group Feb 2, 2018
K180036 — SMAXEL CO2 Surgical Laser SystemIds, Ltd. Feb 2, 2018
K180070 — SpeediCath Flex Coude ProColoplast Feb 2, 2018
K171402 — KARL STORZ Slim NasopharyngolaryngoscopeKARL STORZ Endoscopy-America, Inc. Feb 2, 2018
K173445 — Materialise TKA Guide SystemMaterialise NV Feb 2, 2018
K172512 — ACRO HCG Pregnancy Rapid TestAcro Biotech, Inc. Feb 2, 2018
K172105 — The Plateau-LO Spacer SystemLife Spine, Inc. Feb 2, 2018
K172237 — Bicera Resorbable Bone SubstituteWiltrom Corporation Limited Feb 2, 2018
K170112 — IMD's Lumbar Puncture NeedleInternational Medical Development, Inc.(Imd) Feb 2, 2018
K171450 — Glooko Mobile Insulin Dosing SystemGlooko, Inc. Feb 2, 2018
K173800 — Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy CageCamber Spine Technologies Feb 2, 2018
K172828 — Double Medical Cage SystemDouble Medical Technology, Inc. Feb 1, 2018
K171287 — Sporview VH202 BISpsmedical Supply Corp. A Division Of Cantel Medical Feb 1, 2018
K172789 — Specimen Retrieval BagBeijing Hangtian Kadi Technology R&D Institute Feb 1, 2018
K171662 — Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral CatheterCook Incorporated Feb 1, 2018
K173957 — ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Feb 1, 2018
K180039 — ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Feb 1, 2018
K172395 — Duatene bilayer meshSofradim Production Feb 1, 2018
K171629 — ABCcolla Bone GraftAcro Biomedical Co., Ltd. Feb 1, 2018
K171384 — Micromed BRAIN QUICK systemMicromed S.P.A. Feb 1, 2018
K173443 — AEON Endoscopic StaplerLexington Medical, Inc. Feb 1, 2018
K173047 — The Solstice OCT SystemLife Spine, Inc. Feb 1, 2018
K161989 — PREMIUM Implant Systems SHELTA Implant SystemsSweden & Martina S.P.A. Feb 1, 2018
K172146 — MERISTEELM/S. Meril Endo Surgery Private Limited. Feb 1, 2018
K172509 — Sentosa SA201 HSV 1/2 Qualitative PCR TestVela Diagnostics USA, Inc. Feb 1, 2018
K173601 — Merit SyringeMerit Medical Systems, Inc. Jan 31, 2018
K172643 — da Vinci Xi Surgical System; da Vinci X Surgical SystemIntuitive Surgical, Inc. Jan 31, 2018
K172845 — Symetri ClearOrmco Corporation Jan 31, 2018
K171297 — AR_N Type Implant SystemBiotem Co., Ltd. Jan 31, 2018
K171396 — ODFS Pace XLOdstock Medical, Ltd. Jan 31, 2018
K172240 — SPI Dental Implant SystemMsi France Jan 31, 2018
K173530 — Indego(R)Parker-Hannifin Corporation Jan 31, 2018
K172567 — GORE Molding and Occlusion Balloon CatheterW. L. Gore And Associates, Inc. Jan 31, 2018
K180010 — AtriClip FLEX-VAtriCure, Inc. Jan 31, 2018
K171772 — Ecosite Bulk FillDmg USA, Inc. Jan 31, 2018
K173088 — Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation Jan 31, 2018
K173436 — Luma Light SystemLuma Therapeutics Jan 30, 2018
K171500 — Uro-V CystoscopeUroviu Corporation Jan 30, 2018
K173389 — Rex Medical Aspiration PumpRex Medical, L.P. Jan 30, 2018
K173417 — Zimmer Persona Personalized Knee SystemZimmer, Inc. Jan 30, 2018
K172159 — Getinge GSS67N Series Steam SterilizerMaquet GmbH Jan 30, 2018
K171835 — Irradiation Aesthetic DeviceChongqing Peninsula Medical Technology Co., Ltd. Jan 30, 2018
K170438 — MiroCam Capsule Endoscope SystemIntromedic Co., Ltd. Jan 30, 2018
K173596 — Rusch Intermittent Urethral CathetersTeleflex Medical Jan 29, 2018
K173814 — DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical Jan 29, 2018
K163081 — 40-42mm BiPolar Head and 22mm Femoral HeadSignature Orthopaedics Pty, Ltd. Jan 29, 2018
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