FDA 510(k) clearances — page 262
clearances on record, most recent first.
Clearances — page 262
26,101–26,200 of 176,542- K173147 — SuperNO2VA Et Device
- K180008 — Penumbra System
- K180377 — Fracture and Correction System
- K180743 — Balanced Knee Revision System - Offset Junction Box
- K180885 — HairMax Laser
- K180911 — Visura Technologies TEECAD System
- K181348 — Cartiva SCI Disposable Instrumentation Set
- K181358 — Televere Digital Dental Imaging System
- K181364 — Swiss LithoClast Trilogy
- K181368 — VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL)
- K172346 — sterEOS Workstation
- K173139 — Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus
- K173316 — SpeedBird Model SB38 Soft Tissue Biopsy Device +2 more
- K173700 — PICOPLUS Laser System
- K173905 — Surgic Pro, Surgic Pro+
- K180472 — ViSi Mobile Monitoring System
- K180710 — Reprocessed DecaNav Diagnostic Electrophysiology Catheter
- K180847 — Neutrogena Light Therapy Acne Mask+
- K180856 — Neutrogena Light Therapy Aging Mask+
- K181389 — Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform
- K172345 — IU Implant System
- K172842 — GCE704 Breast Pump
- K172895 — AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819
- K180560 — Sherlock 3CG+ T ip Confirmation System
- K180726 — Savion DLVR Guidewire, Savion FLX Guidewire
- K180761 — SD LTM STIM Cortical Stimulator
- K181484 — Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue
- K181325 — FlowTriever Retrieval/Aspiration System
- K170835 — Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE
- K172551 — Trinity PLUS Acetabular Shell
- K172954 — Medline Prevention CoolZone Gown
- K173225 — Interlude and private label Unscented 3-piece compact applicator tampon
- K173507 — Prodiva 1.5T CX and Prodiva 1.5T CS R5.4
- K173908 — DESS Dental Smart Solutions
- K173936 — Natus Photic Stimulator
- K180497 — Scone Mask
- K180749 — Life Spine SIMPACT Sacroiliac Joint Fixation System
- K181113 — CoLink Afx Plating System
- K181290 — Fusion Bx 2.0
- K172011 — LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)
- K172787 — Access hsTnl
- K172800 — Portex® Lancet Point Spinal Needles with NRFit connectors, Portex® Pencil Point Spinal Needles with NRFit connectors
- K172938 — Disposable Sterile Needle
- K172985 — Ligation Device
- K173376 — ASI Evolution
- K173455 — SurgTech Bipolar Head System
- K173780 — EchoMD Automated Ejection Fraction Software
- K173977 — CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module
- K180100 — MRIaudio PREM System
- K180290 — Natus Brain Monitor Amplifier
- K180401 — TiWAVE-C Porous Titanium Cervical Cage
- K180502 — S128 Anterior Lumbar Interbody Fusion (ALIF) System
- K180505 — Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White)
- K180719 — InMode Diolaze System
- K180738 — COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter
- K180813 — BTL 799-2
- K181280 — Patello-Femoral Wave (Kahuna) Arthroplasty System
- K181301 — Smart External Drain (SED) System
- K181316 — POGO Automatic Blood Glucose Monitoring System
- K181351 — Double Flexible Tipped Wire Guides
- K172983 — HealthCCS
- K173259 — Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories
- K180565 — PEAK NS033CF, PEAK NS017CF
- K180675 — Atlas Spine Expandable Cervical Interbody System
- K180681 — Aptima Combo 2 Assay (Panther System)
- K180818 — Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)
- K180861 — Vinyl Examination Glove (Clear, Non-Colored)
- K180989 — PEDRA-17F Digital Flat Panel X-ray Detector
- K181050 — Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)
- K181271 — Signature Orthodontic System
- K181279 — Ysio Max
- K181298 — Harmony XL Multi-Application Platform
- K181363 — EcoVue Sterile and Non-Sterile Ultrasound Gels
- K181429 — CELERITY 20 HP Biological Indicator
- K181442 — VERIFY Assert Self-Contained Biological Indicator
- DEN170043 — DreaMed Advisor Pro
- K172783 — Access hs Tnl
- K172823 — Portex NRFit Epidural Needles
- K172831 — Perfusor® Space Syringe Infusion Pump System
- K172833 — E-XPE Acetabular Components and U-Motion II Acetabular Cup
- K180124 — ZQuiet
- K180260 — Powder Free Vinyl Patient Examination Gloves (Yellow, White)
- K180452 — White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim
- K181093 — SyMRI
- K181343 — HeartSee Cardiac P.E.T. Processing Software
- K171422 — Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color
- K172821 — Ti-one 101 TS Dental Implant System
- K172835 — GRI-Alleset Veress Needle
- K172961 — LIAC HWL
- K173200 — SOFIA Plus Aspiration Catheter
- K173503 — Pollogen Legend System
- K173787 — X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE® System, CONCORDE® Inline Lumbar Interbody System, CONCORDE® Curve Lumbar Interbody System, CONCORDE® Bullet Lumbar Interbody System, COUGAR® System, COUGAR® LS Lateral Cage System, DEVEX® System, LEOPARD® System, DePuy PULSE Cervical Cage System, DePuy PULSE Lumbar Cage System, LUMBAR I/F CAGE® System
- K173803 — Omnican fine
- K180649 — BeautiCem Veneer Kit
- K180722 — CAPERE Thrombectomy System
- K180766 — Endiscope, Endiscope Cervical
- K180849 — Vinyl Examination Glove (Clear, Non-Colored)
- K180959 — Phenom 27 Catheter
- K181281 — Altus Spine Pedicle Screw System
- K172725 — VT Dressing Kits
Data sourced from openFDA. This site is unofficial and independent of the FDA.