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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
37321–37344 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 21, 2014
SURGISEAL TWIST TOPICAL SKIN ADHESIVE
K141215 · MPN
Adhezion Biomedical, LLC
General & Plastic Surgery · 101d
Cleared Aug 21, 2014
TENSYN BAND, TENSYN FRACTURE PLATES
K141264 · HTN
Dallen Medical, Inc.
Orthopedic · 98d
Cleared Aug 21, 2014
BARRX FLEX RFA ENERGY GENERATOR
K141357 · GEI
Covidien Iic
General & Plastic Surgery · 90d
Cleared Aug 21, 2014
ROMEO 2 PAD POSTERIOR AXIAL DEVICE
K141508 · PEK
Spineart
Orthopedic · 76d
Cleared Aug 21, 2014
MUSTANG BALLOON DILATATION CATHETER/CHARGER PTA BALLOON DILATATION CATHETER
K141521 · LIT
Boston Scientific Corporation
Cardiovascular · 73d
Cleared Aug 21, 2014
IGROW - II HAIR GROWTH SYSTEM, IGROW HAIR GROWTH SYSTEM
K141567 · OAP
Apira Science, Inc.
General & Plastic Surgery · 70d
Cleared Aug 21, 2014
SMITH & NEPHEW DISPOSABLE FIN PUNCH
K141585 · JWH
Smith & Nephew, Inc.
Orthopedic · 69d
Cleared Aug 21, 2014
OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2ML
K141930 · NDN
Osseon, LLC
Orthopedic · 36d
Cleared Aug 21, 2014
SYMBIA 6.0
K142006 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Aug 21, 2014
VALOR HINDFOOT FUSION NAIL SYSTEM
K142121 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 17d
Cleared Aug 21, 2014
ORTHOHELIX STAPLE SYSTEM
K142148 · JDR
Orthohelix Surgical Designs, Inc.
Orthopedic · 16d
Cleared Aug 20, 2014
NEXUS MIDLINE CT CATHETER
K140270 · FOZ
Health Line International Corporation
General Hospital · 198d
Cleared Aug 20, 2014
ANKYLOS C/X IMPLANT SYSTEM
K140347 · DZE
Dentsply Intl., Inc.
Dental · 190d
Cleared Aug 20, 2014
HIOSSEN PROSTHETIC SYSTEM
K140507 · NHA
Osstem Implant Co., Ltd.
Dental · 174d
Cleared Aug 20, 2014
TENURE4G
K140537 · KLE
Den-Mat Holdings, LLC
Dental · 169d
Cleared Aug 20, 2014
ONE STEP SINGLE/MULTI-DRUG TEST CUP, ONE STEP SINGLE/MULTI-DRUG TEST DIPCARD
K140748 · DJG
Co-Innovation Biotech Co., Ltd.
Toxicology · 148d
Cleared Aug 20, 2014
STRAUMANN BONE LEVEL TAPERED IMPLANT
K140878 · DZE
Straumann USA, LLC
Dental · 135d
Cleared Aug 20, 2014
MULTIPIEZO PRO, MULTIPIEZO
K140965 · ELC
Mectron S.P.A.
Dental · 127d
Cleared Aug 20, 2014
NUTRA LIGHT RED
K141308 · OHS
Nutra Luxe MD, LLC
General & Plastic Surgery · 93d
Cleared Aug 20, 2014
OBSIDIAN MILLING BLOCKS
K141788 · EIH
Prismatik Dentalcraft, Inc.
Dental · 49d
Cleared Aug 19, 2014
SONOSENTRY
K131285 · PHZ
Isonea, Ltd.
Anesthesiology · 470d
Cleared Aug 19, 2014
VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE
K133952 · NGZ
bioMerieux, Inc.
Microbiology · 239d
Cleared Aug 19, 2014
OPA 30 SOLUTION
K140703 · MED
Ciden Technologies, LLC
General Hospital · 152d
Cleared Aug 19, 2014
NOMAD MD 75K V HANDHELD X-RAY SYSTEM
K140723 · IZL
Aribex, Inc.
Radiology · 151d