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
57457–57480 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 07, 2008
SIDEKICK RAIL FIXATOR
K080071 · KTT
Wrightmedicaltechnologyinc
Orthopedic · 27d
Cleared Feb 07, 2008
CHALLENGER/CLASSIC PUSH BUTTON HANDPIECE
K080240 · EFB
Promident, LLC
Dental · 7d
Cleared Feb 06, 2008
SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB,...
K062798 · FGE
Cordis Corp.
Gastroenterology & Urology · 505d
Cleared Feb 06, 2008
ATLAS IMPLANT SYSTEM
K071148 · DZE
Cowellmedi Co., Ltd.
Dental · 288d
Cleared Feb 06, 2008
OPTION SMARTCARE FOR EVITAXL,SMARTCARE KIT CAPNO PACKAGE, CO2 SENSOR...
K072412 · CBK
Drager Medical AG & Co. Kgaa
Anesthesiology · 163d
Cleared Feb 06, 2008
DYNASTY CERAMIC FEMORAL HEAD
K072656 · LZO
Wrightmedicaltechnologyinc
Orthopedic · 139d
Cleared Feb 06, 2008
ORTHOPILOT 2 TOTAL HIP ARTHROPLASTY (THA) VERSION 3.0
K072899 · HAW
Aesculap Implant Systems, Inc.
Neurology · 118d
Cleared Feb 06, 2008
MERITS E600 SERIES STAIR LIFT
K073110 · ILK
Merits Health Products Co., Ltd.
Physical Medicine · 93d
Cleared Feb 06, 2008
ORAL-B SUB-BRAND MANUAL TOOTHBRUSH
K073224 · EFW
Procter & Gamble
Dental · 83d
Cleared Feb 06, 2008
PSL BIOZIR BLOCK
K073568 · EIH
P.S.L. International, Inc.
Dental · 48d
Cleared Feb 06, 2008
FUJIFILM UNITY SPEEDSUITE, MODEL CR-IR 371
K073650 · KPR
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 42d
Cleared Feb 06, 2008
MSK EXTREME MR SCANNER, MODEL AA5000
K080048 · LNH
Oni Medical Systems, Inc.
Radiology · 29d
Cleared Feb 06, 2008
DENFIL ETCHANT-37
K080265 · EBF
Vericom Co., Ltd.
Dental · 5d
Cleared Feb 06, 2008
WELL-PEX
K080266 · KIF
Vericom Co., Ltd.
Dental · 5d
Cleared Feb 05, 2008
PATHFAST NTPROBNP AND D-DIMER TESTS
K072189 · NBC
Mitsubishi Kagaku Iatron
Chemistry · 183d
Cleared Feb 05, 2008
VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM
K072254 · GWN
Interacoustics A/S
Neurology · 175d
Cleared Feb 05, 2008
ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET
K072437 · NBC
Roche Diagnostics
Chemistry · 166d
Cleared Feb 05, 2008
BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM
K073626 · GWJ
Bio-Logic Systems Corp.
Neurology · 41d
Cleared Feb 05, 2008
NRBC-CHEX FOR ADVIA
K080016 · GJR
Streck
Hematology · 33d
Cleared Feb 05, 2008
MODIFICATION TO:HEALTH BUDDY APPLIANCE
K080091 · DRG
Health Hero Network, Inc.
Cardiovascular · 22d
Cleared Feb 04, 2008
TOTAL HIP PROSTHESIS SYSTEM QUADRA S + COCRMO FEMORAL BALL HEAD + APRICOT
K072857 · JDI
Medacta International S.A.
Orthopedic · 122d
Cleared Feb 04, 2008
PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY
K072908 · KPO
Gambro Renal Products
Gastroenterology & Urology · 115d
Cleared Feb 04, 2008
MS SYSTEM (DENTURE)
K072959 · DZE
Osstem Implant Co., Ltd.
Dental · 108d
Cleared Feb 04, 2008
STATMATIC 31 HANDPIECE MAINTENANCE UNIT
K073319 · EFB
Scican , Ltd.
Dental · 70d