510(k) Clearances — Page 112

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 112 of 3,525)
ClearancesDetails
K243297 — APRO 70 Swift CatheterAlembic, LLC Jan 14, 2025
K241037 — ABL90 FLEX PLUS SystemRadiometer Medicals Aps Jan 14, 2025
K241166 — uCT 550Shanghai United Imaging Healthcare Co., Ltd. Jan 14, 2025
K243272 — LOCATOR Angled AbutmentZest Anchors, LLC Jan 14, 2025
K242672 — Zoom SystemImperative Care, Inc. Jan 14, 2025
K242205 — SpectoMed (v1.0)Specto Medical Jan 14, 2025
K241180 — Consensus Knee System with TiNbNShalby Advanced Technologies Jan 14, 2025
K243904 — Elegance® Anterior Cervical plateClariance Jan 14, 2025
K241278 — ASEPT® Glide Peritoneal Drainage SystemPfm Medical, Inc. Jan 14, 2025
K243577 — Radical the Dude 8F Guide CatheterMaduro Medical, Inc. Jan 14, 2025
K243527 — High Flow Insufflation Unit (UHI-4)Olympus Medical Systems Corporation Jan 13, 2025
K233452 — Vivo 45 LSBreas Medical AB Jan 13, 2025
K243791 — Air Pressure Therapy SystemXiamen Weiyou Intelligent Technology Co., Ltd. Jan 13, 2025
K242030 — MegaGen Dental Implant AbutmentMegagen Implant Co., Ltd. Jan 13, 2025
K243950 — ARVIS® ShoulderKico Knee Innovation Company Pty, Ltd. Jan 13, 2025
K241200 — SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening OptionArineta , Ltd. Jan 13, 2025
K243890 — Arthrex Intramedullary NailsArthrex, Inc. Jan 13, 2025
K243533 — Sterilized Eol Auto Lancet; Sterilized Eol Lancet PlusHlb Co., Ltd. Healthcare Jan 13, 2025
K243295 — Initia Knee SystemKyocera Medical Technologies, Inc. Jan 13, 2025
K243262 — QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro TestOsang, LLC Jan 13, 2025
K243271 — MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel SizerMentor Worldwide, LLC Jan 13, 2025
K243909 — Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal ToricAlcon Laboratories, Inc. Jan 13, 2025
K241059 — Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A Jan 13, 2025
K242680 — LetsGetChecked ImpressPrivapath Diagnostics Ltd (Dba Letsgetchecked) Jan 13, 2025
K241431 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193)Joytech Healthcare Co. , Ltd. Jan 13, 2025
K242689 — AAMI Level 4 Protective; GownAzac Group Jan 13, 2025
K243836 — Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue ExpanderMentor Worldwide, LLC Jan 12, 2025
K241641 — Electric Wheelchair (YE200)Shenzhen Yattll Industry Co., Ltd. Jan 11, 2025
K241781 — Solo Pace ControlSolo Pace, Inc. Jan 10, 2025
K242366 — OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-AbutmentOverfibers S.R.L. Jan 10, 2025
K242877 — BioCode Gastrointestinal Pathogen Panel (GPP)Applied BioCode, Inc. Jan 10, 2025
K243806 — Safety Winged Blood Collection SetsPromisemed Hangzhou Meditech Co., Ltd. Jan 10, 2025
K241009 — PeriCALM Patterns 3.0Perigen, Inc. Jan 10, 2025
K242901 — ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)Tools For Surgery, LLC Jan 10, 2025
K243492 — Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd. Jan 10, 2025
K243111 — Bowhead ERA WheelchairsBowhead Design Corp. Jan 10, 2025
K242767 — Safecare Urinary Tract Infection TestSafecare Biotech (Hangzhou) Co., Ltd. Jan 10, 2025
K241764 — Mould Probe MR SafeVarian Medical Systems, Inc. Jan 10, 2025
K241891 — ScreenDxImvaria, Inc. Jan 10, 2025
K241064 — Unscented TamponShandong Intco Hygiene Products Co., Ltd. Jan 10, 2025
K243195 — Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc. Jan 10, 2025
K243477 — Universal Tendon SpacerAskorn Medical Jan 10, 2025
K243814 — NuVasive Pulse SystemGlobus Medical, Inc. Jan 10, 2025
K242228 — Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01)Triopsy Medical, Inc. Jan 10, 2025
K241676 — TriVerityInflammatix, Inc. Jan 10, 2025
K242528 — Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK268, RAK269, RAK282, RAK283, RAK286, RAK288, RAK289, RAK291, RAK292, RAK293, RAK295, RAK296, RAK297, RAK298)Shenzhen Ruiankang Technology Co., Ltd. Jan 10, 2025
K241174 — INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)Carl Zeiss Meditec, AG Jan 10, 2025
K242071 — Xpert Xpress CoV-2/Flu/RSV plusCepheid Jan 10, 2025
K240267 — Klaxon (Twist); Klaxon (Twist R)Klaxon Mobility GmbH Jan 10, 2025
K243811 — Erchonia Zerona® VZ8Erchonia Corporation Jan 10, 2025
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