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
43369–43392 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 06, 2012
LOUTREX TOPICAL CREAM
K120730 · FRO
Acella Pharmaceuticals, LLC
General & Plastic Surgery · 181d
Cleared Sep 06, 2012
LENSSX LASER SYSTEM
K120732 · HQC
Alcon Lensx, Inc.
Ophthalmic · 181d
Cleared Sep 06, 2012
PADLOCK CLIP-12
K120814 · PKL
Aponos Medical Corp.
Gastroenterology & Urology · 171d
Cleared Sep 06, 2012
ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE
K121309 · OTJ
Advanced Surgical Concepts
General & Plastic Surgery · 128d
Cleared Sep 06, 2012
CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
K121974 · HSX
Conformis, Inc.
Orthopedic · 63d
Cleared Sep 06, 2012
MAXLOCK EXTREME SYSTEM
K122005 · HRS
Orthohelix Surgical Designs, Inc.
Orthopedic · 59d
Cleared Sep 06, 2012
LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM
K122397 · LFX
DiaSorin, Inc.
Microbiology · 30d
Cleared Sep 06, 2012
DEPUY CTA REVERSE SHOULDER SYSTEM
K122442 · PHX
Depuy France
Orthopedic · 27d
Cleared Sep 06, 2012
SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES
K122628 · DSP
Datascope Corp., Cardiac Assist Division
Cardiovascular · 9d
Cleared Sep 05, 2012
NEOSS PROACTIVE TAPERED IMPLANT
K113376 · DZE
Neoss, Ltd.
Dental · 294d
Cleared Sep 05, 2012
LIGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER
K113572 · GEI
Covidien, Formerly Valleylab, A...
General & Plastic Surgery · 278d
Cleared Sep 05, 2012
TEST, BLOOD GLUCOSE SYSTEM
K120064 · NBW
Hmd Biomedical, Inc.
Chemistry · 240d
Cleared Sep 05, 2012
TIXOS IMPLANT SYSTEM
K120792 · DZE
Leader Italia S.R.L.
Dental · 174d
Cleared Sep 05, 2012
METS SMILES TOTAL KNEE REPLACEMENT
K120992 · KRO
Stanmore Implants Worldwide , Ltd.
Orthopedic · 156d
Cleared Sep 05, 2012
PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL...
K121383 · FJS
Medical Components, Inc.
Gastroenterology & Urology · 120d
Cleared Sep 05, 2012
MOLLRING MULTITASC
K121415 · DWX
LeMaitre Vascular, Inc.
Cardiovascular · 117d
Cleared Sep 05, 2012
AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK...
K121654 · CGA
I-Sens, Inc.
Chemistry · 92d
Cleared Sep 05, 2012
BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTS
K121787 · DZE
BioHorizons Implant Systems, Inc.
Dental · 79d
Cleared Sep 05, 2012
STRYKER SDC3 HD INFORMATION MANAGEMENT SYSTEM
K121893 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 68d
Cleared Sep 05, 2012
LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON
K122030 · KNT
Degania Silicone , Ltd.
Gastroenterology & Urology · 56d
Cleared Sep 05, 2012
RELIANCE ANTERIOR CERVICAL PLATE SYSTEM
K122216 · KWQ
Reliance Medical Systems, LLC
Orthopedic · 42d
Cleared Sep 05, 2012
FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON...
K122379 · LIT
Ostial Corporation
Cardiovascular · 30d
Cleared Sep 05, 2012
TERUMO SURFLASH SAFETY I.V. CATHETER
K122544 · FOZ
Terumo Corporation
General Hospital · 15d
Cleared Sep 05, 2012
UGEO G60 DIAGNOSTIC ULTRASOUND SYSTEM
K122583 · IYN
Samsung Medison Co., Ltd.
Radiology · 12d