510(k) Clearances — Page 158

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 158 of 3,525)
ClearancesDetails
K232302 — Pocket IIIQuantel Medical Apr 26, 2024
K232435 — Rhinolaryngoscope systemShenzhen HugeMed Medical Technical Development Co., Ltd. Apr 26, 2024
K240406 — Sonio DetectSonio Apr 26, 2024
K233583 — FCT iSTREAM Phase 1FUJIFILM Healthcare Americas Corporation Apr 26, 2024
K232799 — syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. Apr 26, 2024
K233873 — XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited Apr 26, 2024
K240299 — Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc. Apr 26, 2024
K231142 — Temporis, Irix PlusDws S.R.L. Apr 25, 2024
K232357 — Copan Universal Transport Medium (UTM-RT) SystemCopan Italia Spa Apr 25, 2024
K232405 — ENDOFIX EXOAktormed GmbH Apr 25, 2024
K240535 — Digital ClarusScope System; Digital NeuroPEN SystemClarus Medical, LLC Apr 25, 2024
K233810 — Portrait VSMGe Medical Systems Information Technologies, Inc. Apr 25, 2024
K232331 — InVision Precision LVEF (LVEF)InVision Medical Technology Corporation Apr 25, 2024
K232246 — 1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION™ PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless SutureM/S. Meril Endo Surgery Private Limited. Apr 25, 2024
K233308 — Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)Nakanishi, Inc. Apr 25, 2024
K232805 — Kronos Electrocautery DeviceSingle Pass, Inc. Apr 25, 2024
K240846 — CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone CementCarboFix Orthopedics , Ltd. Apr 25, 2024
K234065 — CDI OneView Monitoring SystemTerumo Cardiovascular Systems Corporation Apr 25, 2024
K232796 — LUOFUCON® Collagen Particles (Collagen Wound Dressing)Huizhou Foryou Medical Devices Co., Ltd. Apr 25, 2024
K240855 — Dental Cone-beam Computed TomographyYian Medical Technology (Haining) Co., Ltd. Apr 25, 2024
K233172 — NextAR™ Spine PlatformMedacta International S.A. Apr 24, 2024
K234025 — 22.2mm BIOLOX® delta Ceramic V40™ Femoral HeadsHowmedica Osteonics Corp., Dba Stryker Orthopaedics Apr 24, 2024
K233764 — SSS-NX (Serum Substitute Supplement-NX)Fujifilm Irvine Scientific Apr 24, 2024
K240623 — Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC Apr 24, 2024
K240208 — DESS Dental Smart SolutionsTerrats Medical SL Apr 24, 2024
K234056 — canturio® se (Canturio Smart Extension)Canary Medical USA, LLC Apr 24, 2024
K232181 — Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13)Hebei JT Medical Co., Ltd. Apr 24, 2024
K240093 — IPL Home Use Hair Removal Device (SJ15)Shenzhen Shuge Medical Beauty Devices Co., Ltd. Apr 24, 2024
K240822 — Image Management V15Philips Medical Systems Technologies Apr 24, 2024
K240850 — EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC Apr 24, 2024
K240839 — OpenRad CloudOpenrad Services Uk, Ltd. Apr 24, 2024
K240319 — DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)Pro Med Instruments GmbH Apr 24, 2024
K234147 — ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR Handpiece, 34cm, with Reference Markings (3941M); ReNew XR Handpiece, 42cm, with Reference Markings (3942M); ReNew XR Handpiece, Ratcheted, 25cm, with Reference Markings (3946M); ReNew XR Handpiece, Ratcheted, 34cm, with Reference Markings (3944M); ReNew XR Handpiece, Ratcheted, 42cm, with Reference Markings (3945M)Microline Surgical, Inc. Apr 23, 2024
K240816 — MeDioStarAsclepion Laser Technologies GmbH Apr 23, 2024
K233537 — FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc. Apr 23, 2024
K240518 — swiftPro™ SystemEmblation Limited Apr 23, 2024
K234107 — Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)Laborie Medical Technologies, Corp. Apr 23, 2024
K222958 — mJOULE RF System and AccessoriesSciton, Inc Apr 23, 2024
K233329 — Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing SetRoute 92 Medical, Inc. Apr 23, 2024
K240902 — Dexcom G7 Continuous Glucose Monitoring SystemDexcom, Inc. Apr 23, 2024
K233849 — BTL-499BTL Industries, Inc. Apr 23, 2024
K240058 — AEYE-DSAeye Health, Inc. Apr 23, 2024
K231699 — QUANTUM® Patient Specific Instrumentation (PSI) SystemIn2Bones Sas Apr 23, 2024
K233948 — Provisio™ SLT IVUS™ SystemProvisio Medical, Inc. Apr 23, 2024
K232319 — Black Pearl Nitrile Examination GloveUg Global Resources Sdn. Bhd. Apr 22, 2024
K223515 — MamaLift PlusCurio Digital Therapeutics, Inc. Apr 22, 2024
K240115 — Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, NuewaI8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. Apr 22, 2024
K233966 — Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc. Apr 22, 2024
K234041 — Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5811BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5810VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5810BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5920VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5920BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5923TS)Andon Health Co, Ltd. Apr 22, 2024
K233582 — RapidIschemaview, Inc. Apr 22, 2024
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