510(k) Clearances — Page 141

176,223 clearances total

Browse all FDA 510(k) medical device clearances. RegDataLab tracks 176,223 clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances (page 141 of 3,525)
ClearancesDetails
K241268 — Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)Exceleron Medical Aug 2, 2024
K241919 — Innovita HCG Pregnancy Rapid Combo TestInnovita (Tangshan) Biological Technology Co., Ltd. Aug 2, 2024
K241181 — Disposable Ureteral Guide SheathDongguan Zsr Biomedical Technology Company Limited Aug 2, 2024
K242055 — Freefix Forearm Plating SystemSkeletal Dynamics, Inc. Aug 1, 2024
K240301 — MammoScreen® (3)Therapixel Aug 1, 2024
K241105 — 3MP Color LCD Monitor (CL-S301)Jvckenwood Corporation Aug 1, 2024
K241145 — TLAB® Transvenous Liver Biopsy System (TF-18C)Argon Medical Devices, Inc. Aug 1, 2024
K233580 — A Breathing System (ABS)Deepwell Dtx, Inc. Aug 1, 2024
K240035 — TACTIX Vector Syndesmosis SystemVilex, LLC Aug 1, 2024
K234141 — AISAP Cardio V1.0Aisap Aug 1, 2024
DEN230046 — PGDx elio plasma focus DxPersonal Genome Diagnostics, Inc. Aug 1, 2024
K233731 — CardIQ SuiteGE Medical Systems SCS Aug 1, 2024
K232469 — Rüsch Latex Gold Foley CatheterTeleflexmedical, Inc. Aug 1, 2024
K241238 — LOOP™ LED Curing Light System (CLK01)Garrison Dental Solutions, LLC Aug 1, 2024
K233793 — CarboClear® X Pedicle Screw SystemCarboFix Orthopedics , Ltd. Aug 1, 2024
K240312 — Infinity CentralStation WideDraeger Medical Systems, Inc. Aug 1, 2024
K241945 — KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1)Karl Storz SE & CO. KG Aug 1, 2024
K242046 — EXULT Knee Replacement SystemCorentec Co., Ltd. Aug 1, 2024
K241140 — ViroZap Indoor Air Purifier, In Duct Model 1008Applied Photonix, LLC Aug 1, 2024
K233942 — PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 )Pentax Of America, Inc. Aug 1, 2024
K233696 — DePuy Synthes Retrograde Femoral Nail Advanced SystemDePuy Synthes Aug 1, 2024
K240805 — Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)Pelvital USA, Inc. Aug 1, 2024
K241690 — Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd. Aug 1, 2024
K241137 — Clear Moves AlignerClear Moves Aligners Aug 1, 2024
K233808 — LW Narrow Implant SystemOssvis Co., Ltd. Jul 31, 2024
K240898 — SteriTite rigid reusable sterilization container with MediTray ProductsCase Medical Jul 31, 2024
K241934 — NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)Anx Robotica Corp Jul 31, 2024
K233555 — AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face MaskPhilips Respironics Jul 31, 2024
K240967 — ValvuloPro Valvuloplasty Balloon CatheterDongguan TT Medical, Inc. Jul 31, 2024
K241225 — Silverlon® Wound Contact, Burn Contact DressingArgentum Medical, LLC Jul 31, 2024
K241917 — EARP Nerve Cuff ElectrodeRetropsoas Technologies, LLC Jul 31, 2024
K240578 — VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter SystemB.Braun Medical, Inc. Jul 31, 2024
K233541 — ARCHITECT Active-B12 (Holotranscobalamin)Axis-Shield Diagnostics, Ltd. Jul 31, 2024
K240446 — Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax +Shiva Products Jul 30, 2024
K241539 — Activmotion SNewclip Technics Jul 30, 2024
K240531 — SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank AbutmentBioHorizons Implant Systems, Inc. Jul 30, 2024
K240280 — Nano-Check™ RSV TestNano-Ditech Corporation Jul 30, 2024
K241963 — WERAYPicopack Co., Ltd. Jul 30, 2024
K240326 — Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc. Jul 29, 2024
K241906 — BioBrace® Reinforced ImplantConmed Corporation Jul 29, 2024
K241912 — BIOCHARGENanofiber Solutions, LLC Jul 29, 2024
K242050 — Montage Settable Bone PuttyOrthocon, Inc. Jul 29, 2024
K234125 — AtriClip FLEX-Mini LAA Exclusion System (ACHM)AtriCure, Inc. Jul 29, 2024
K233723 — Medical surgical maskGuangdong Kingfa Sci. & Tech.Co., Ltd. Jul 29, 2024
K240359 — PowerGlide Pro™ Midline CatheterBecton, Dickinson And Company (Bard Access Systems, Inc.) Jul 29, 2024
K241464 — ARx® SAI Implant SystemLife Spine, Inc. Jul 29, 2024
K241209 — EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd. Jul 29, 2024
K234131 — Resolv Endoscopic Hemostat SystemHemostasis, LLC Jul 26, 2024
K233994 — VOLT™ Proximal Humerus 3.5 Plating SystemSynthes GmbH Jul 26, 2024
K241866 — InnovaMatrix®FDConvatec Triad Life Sciences, LLC Jul 26, 2024
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