FDA 510(k) clearances — page 9
clearances on record, most recent first.
Clearances — page 9
801–900 of 176,428- K262014 — PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves
- K254231 — Inno-Hook Disposable Clip Appliers (Ligating Clips) and Inno-Hook Ligating Clips
- K254285 — Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Aqua Blue +3 more
- K260516 — BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)
- K261011 — Sleep Apnea Feature (v2.0)
- K261535 — Hi-D Imaging 4TAVR
- K261573 — ENDOSCOPE HOLDER (182214)
- K261632 — Thunderbolt System
- DEN250040 — SportSuite Vision Software
- K251952 — Virasight
- K253011 — Catalyft PL Expandable Interbody System
- K253694 — Natural Cycles
- K253963 — Cubresa BrainPET
- K254006 — Drivewire 35 Guidewire
- K260694 — ZEISS CLINIC 360
- K261046 — Dental Zirconia Blank & Coloring Liquid
- K261475 — BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit
- K261614 — LED LCD Monitor (OEV-271H)
- K261658 — LoFric Origo Pro Coudé
- K261675 — CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D)
- K261693 — Diode laser hair removal machine (QDTM-04)
- K261984 — AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup
- K262061 — Tritanium® C Anterior Cervical Cage +16 more
- K260002 — Socrates Aspiration System (Socrates 70 Aspiration Catheter)
- K260021 — cobas® BV/CV
- K261271 — Cable-Ready® Cable Grip System
- K261309 — Palisades Buttress Plate System
- K261674 — Skin Air Cooling System (QALF-01)
- K261706 — Endomat Select (UP220)
- K262032 — TriMed Non-Spanning Wrist Fusion Plates (4 models)
- K252822 — Atlas Spine HiRISE Expandable Cervical-p Corpectomy Implant
- K253606 — NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system
- K260050 — WRAP System
- K260206 — SkeletonPlanner
- K260338 — ThinkSono Guidance
- K260739 — Profoject Pen Needles (Model A; Model B)
- K260851 — Better Diagnostics Dental Assist (BDDA) Version 1.0
- K261353 — Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System
- K261407 — XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE457, XPRE448, XPRE335, XPRE350, XPRE420, XPRE436, XPRE339, XPRE445)
- K262006 — EnSite X EP System
- K262030 — Aventus Thrombectomy System
- K253662 — LIXI (LXOSFM1)
- K253667 — Accoat Guide Wire
- K260578 — Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)
- K261020 — Symmetrix L Spinal System
- K261232 — IERO Mobility Scooter (IERO-01)
- K261249 — Universal Seal (5-12 mm)
- K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System
- K261633 — VisuBreath
- K253504 — Volnewmer
- K254044 — Hearing assist
- K260199 — SLIM Microcatheter
- K260208 — Ultra-Fine SAFETY Insulin Syringe
- K261085 — Rapid Vessel Occlusion (Rapid VO)
- K261199 — Wearable Breast Pump (Model S32A)
- K261640 — Merit MAK Nitinol/Gold-Tungsten Guide Wire
- K253480 — Capenergy C Equipments RF C200 and C400 Drakarian
- K253514 — Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220) +2 more
- K253670 — SmartCT (R3.0 (L10))
- K254037 — LungFlow Airway Catheter
- K254295 — Sofia Lyme FIA; Sofia 2 Campylobacter FIA
- K260880 — SedLine Sedation Monitor
- K260902 — Cochlear Osia® 3(I) Sound Processor +6 more
- K261031 — POSEIDON ST
- K261041 — ClearSafe Closed System
- K261149 — Electric Wheelchair (DY611A-2, DY612A-1)
- K261212 — Flowflex Plus RSV + Flu A/B + COVID Rapid Test
- K261306 — AI Contouring (VA10A)
- K261624 — Omnifit® 20° Series I Insert +11 more
- K261949 — NYES Tuff Cuff L3 Disposable Gowns
- K261978 — WallFlex Esophageal Stent System; Agile Esophageal Over-the-Wire (OTW) Stent System
- K262120 — Avara Viewer
- K252978 — ScioCardio ECG Analysis Platform
- K253899 — 3D-Anywhere
- K253901 — Millipede88 Access Catheter
- K260157 — LifeLens Physiological Monitor
- K260539 — MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter
- K260723 — HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)
- K261166 — DIA-CEM
- K261177 — PINKSLIP Water-Based Personal Lubricant and Moisturizer
- K261471 — Zeta TMS Navigation System
- K261569 — UbiqVue 2AYe Cardiac System (UX2253)
- K261962 — SmartGuard Technology; Predictive Low Glucose Technology
- K261968 — Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981) +1 more
- K261988 — Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture
- K253751 — CXRDetectAI
- K254130 — C.A. Medical Interbody Fusion System
- K260160 — VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
- K260278 — ThermAffyx(TM) Patient Safety System
- K260700 — BlueDop Vascular Expert
- K260750 — Virtual Cone (1.0)
- K260917 — cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems
- K261191 — Alians Elbow S
- K261396 — Electric Wheelchair
- K262300 — Denture Base Resin V2
- K253942 — Pulmonex II Xenon System (132-503)
- K260973 — InferOperate Suite
- K261163 — Mobility Scooter (R200)
- K261164 — Electric wheelchair (XW-LY007 )
- K261812 — HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens +2 more
Data sourced from openFDA. This site is unofficial and independent of the FDA.