Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
57361–57384 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 15, 2008
VF GEL PLUS
K071663 · MIX
Coapt Systems, Inc.
Ear, Nose, Throat · 242d
Cleared Feb 15, 2008
BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 40
K071702 · MNT
Breas Medical AB
Anesthesiology · 239d
Cleared Feb 15, 2008
VINYL EXAMINATION GLOVE POWDER FREE
K072227 · LYZ
Pinnacle Co., Ltd.
General Hospital · 189d
Cleared Feb 15, 2008
MODEL I-2000 MONITOR
K072382 · OLT
Infinite Biomedical Technologies
Neurology · 175d
Cleared Feb 15, 2008
PENTABORN
K072447 · DZE
Mediscitec, Inc.
Dental · 168d
Cleared Feb 15, 2008
3M ESPE ADULT CROWN
K072733 · EBF
3M Company
Dental · 141d
Cleared Feb 15, 2008
SPI VARIOMULTI ABUTMENT
K072856 · NHA
Thommen Medical AG
Dental · 133d
Cleared Feb 15, 2008
ANKYLOS DENTAL IMPLANT SYSTEM/CLAIMS
K073067 · DZE
Dentsply International, Inc.
Dental · 108d
Cleared Feb 15, 2008
HOFFMANN LIGHT SYSTEM
K073076 · KTT
Howmedica Osteonics Corp.
Orthopedic · 107d
Cleared Feb 15, 2008
EXTENDED VERTIFLEX SPINAL SCREW SYSTEM
K073245 · NKB
Vertiflex, Inc.
Orthopedic · 88d
Cleared Feb 15, 2008
BIOHORIZONS SINGLE-STAGE IMPLANT SYSTEM
K073282 · DZE
BioHorizons Implant Systems, Inc.
Dental · 86d
Cleared Feb 15, 2008
GC MODELS OPA-100 AND JC-50
K073588 · DYH
GC America, Inc.
Dental · 57d
Cleared Feb 15, 2008
TRANSBOND SUPREME ADHESIVE
K073697 · DYH
3M Unitek
Dental · 46d
Cleared Feb 15, 2008
APEX DAL ELECTRONIC APEX LOCATOR
K080113 · LQY
Medicnrg , Ltd.
Dental · 30d
Cleared Feb 15, 2008
HUAYI H035 BASIC WHEELCHAIR
K080114 · IOR
Danyang Huayi Medical Supply &...
Physical Medicine · 30d
Cleared Feb 15, 2008
ARTHROCARE CONTROLLERS (SYSTEM 2000,1100,1200), MODEL H2076-00, H2079-00,...
K080282 · GEI
Arthrocare Corp.
General & Plastic Surgery · 11d
Cleared Feb 15, 2008
TRAVEL PAL FOUR WHEEL SCOOTER, MODEL MM114
K080288 · INI
Mega Motion, Inc.
Physical Medicine · 11d
Cleared Feb 14, 2008
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND...
K070947 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 316d
Cleared Feb 14, 2008
GC AADVA ABUTMENT
K072100 · NHA
GC America, Inc.
Dental · 198d
Cleared Feb 14, 2008
PERIOSCAN, MODEL: D 3496
K072107 · ELC
Sirona Dental Systems GmbH
Dental · 198d
Cleared Feb 14, 2008
CORONIS FUSION 6MP DL, MODEL: MDCC 6130 DL
K073007 · LLZ
Barcoview, Medical Imaging Systems
Radiology · 113d
Cleared Feb 14, 2008
THUMPER, MODEL: 1008
K073079 · DRM
Michigan Instruments, Inc.
Cardiovascular · 106d
Cleared Feb 14, 2008
FACTS HAND AND PINCH GRIP COMBO
K073154 · LBB
Global Services Group, LLC
Neurology · 98d
Cleared Feb 14, 2008
CMRTOOLS AND PLUG-INS VENTRICULAR TOOLS & THALASSAEMIA TOOLS
K073194 · LLZ
Cardiovascular Imaging Solutions , Ltd.
Radiology · 93d