510(k) Clearances in 2018 — Page 7

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 7 of 62)
510(k) clearancesDetails
K182380 — AEON Endoscopic StaplerLexington Medical, Inc. Nov 28, 2018
K181604 — Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent BiteHrs Co., Ltd. Nov 28, 2018
K180207 — Non-contact Infrared ThermometerAlicn Medical (Shenzhen), Inc. Nov 28, 2018
K183010 — Smith & Nephew VISIONAIRE Patient Matched Cutting BlocksSmith & Nephew, Inc. Nov 28, 2018
K182169 — AdVance XP Male SlingBoston Scientific Corporation Nov 27, 2018
K182764 — Biop Digital ColposcopeBiop Medical , Ltd. Nov 27, 2018
K182983 — iFuse Implant System®SI-BONE, Inc. Nov 27, 2018
K182746 — ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. Nov 27, 2018
K182353 — EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayPhadia AB Nov 27, 2018
K182801 — Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting CableIntegra LifeSciences Corporation Nov 27, 2018
K182369 — gammaCore SapphireElectrocore, Inc. Nov 27, 2018
K182470 — Plateau Spacer SystemLife Spine Nov 26, 2018
K183013 — Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation Nov 26, 2018
K182134 — ARiX RAD Radiographic SystemCompania Mexicana DE Radiologia Cgr, S.A. DE C.V. Nov 26, 2018
K172837 — Low-frequency Multi-function physiotherapy instrumentShenzhen Osto Technology Co., Ltd. Nov 26, 2018
K183159 — 3M Clarity Aligners3M Company Nov 26, 2018
K182699 — Selethru PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd. Nov 26, 2018
K182431 — Konicaminolta DI-X1Konica Minolta, Inc. Nov 26, 2018
K183009 — HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE BLADESHemostatix Medical Technologies, LLC Nov 26, 2018
K183038 — Corin Optimized Positioning System (OPS) PlanCorin USA Nov 26, 2018
K183174 — FlexCath Advance Steerable Sheath and DilatorMedtronic Cryocath, LP Nov 26, 2018
K181112 — Orchestrate 3DOrchestrate 3D Nov 26, 2018
K182346 — TRULIANT Porous Tibial Tray and Exactech Alteon Bone ScrewsExactech, Inc. Nov 26, 2018
K182324 — EkoSonic Endovascular SystemBtg International, Inc. Nov 26, 2018
K182967 — Visor SystemCerebrotech Medical Systems, Inc. Nov 23, 2018
K182684 — HammerTechTM Fixation SystemFusion Orthopedics, LLC Nov 23, 2018
K180607 — Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA KitKronus, Inc. Nov 23, 2018
K182687 — Motion Tracking and Compensation Feature for the Radixact Treatment Delivery SystemAccuray Incorporated Nov 23, 2018
K180430 — Digistat Smart CentralAscom Ums Srl Unipersonale Nov 23, 2018
K180643 — MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs)Medcu Technologies , Ltd. Nov 23, 2018
K180573 — Responsive Arthroscopy Interference Screw SystemResponsive Arthroscopy, LLC Nov 23, 2018
K181381 — A.B. Dental Devices Dental Implants SystemA.B. Dental Device , Ltd. Nov 23, 2018
K181443 — Accula RSV TestMesa Biotech, Inc. Nov 23, 2018
K180557 — Greene Renal Transplant Stent SetCook Incorporated Nov 23, 2018
K182304 — Hyper GP (tisilfocon A) Daily Wear Contact LensContamac, Ltd. Nov 23, 2018
K182306 — Sunkingdom Slit LampChongqing Sunkingdom Medical Instrument Co., Ltd. Nov 22, 2018
K182977 — Isolette 8000 PlusDraeger Medical Systems, Inc. Nov 21, 2018
K181297 — DENTIOIII series (DENTIOIII, DENTIOIII-S)Hdx Will Corp. Nov 21, 2018
K182909 — Roth Net Retriever Product LineUnited States Endoscopy Group, Inc. Nov 21, 2018
K182779 — ARK EDDP AssayArk Diagnostics, Inc. Nov 21, 2018
K182606 — PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies Ulc. (Now A Part Of Stryker) Nov 21, 2018
K181123 — ApnoDent ApplianceApnomed, Inc. Nov 21, 2018
K182277 — Versana PremierGE Medical Systems Ultrasound And Primary Care Diagnostics Nov 21, 2018
K180546 — Jet Power Injectable PICCJet Medical, Inc. Nov 21, 2018
K181704 — TransparaScreenpoint Medical B.V. Nov 21, 2018
K173744 — ProFuse CADEigen Nov 21, 2018
K182957 — Heli-FX EndoAnchor SystemMedtronic Vascular, Inc. Nov 21, 2018
K182027 — Wet Organics Personal LubricantTrigg Laboratories Dba Wet International Nov 21, 2018
K180541 — DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC Nov 21, 2018
K182581 — PlayMakar Sport Muscle Stimulator, Model PRO-500Playmakar, Inc. Nov 21, 2018
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