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
56257–56280 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 27, 2008
ALMA LASERS FAMILY OF THERMO-XEL HANDPIECES, PIXEL MODELS: 2940, 1060
K072182 · GEX
Alma Lasers , Ltd.
General & Plastic Surgery · 326d
Cleared Jun 27, 2008
NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265
K073537 · MQM
Siemens Medical Solutions Diagnostics
Chemistry · 193d
Cleared Jun 27, 2008
ORQIS EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL BPS-100
K073631 · KFM
Orqis Medical Corporation
Cardiovascular · 184d
Cleared Jun 27, 2008
ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES
K073644 · OCW
Endogastric Solutions, Inc.
Gastroenterology & Urology · 184d
Cleared Jun 27, 2008
IDEAL LIFE GLUCO-MANAGER GMM 0001 BLOOD GLUCOSE MONITORING SYSTEM
K080283 · NBW
Taidoc Technology Corporation
Chemistry · 144d
Cleared Jun 27, 2008
DERMA SCIENCES CALCIUM ALGINATE DRESSING WITH ANTIMICROBIAL SILVER (ALGICELL AG)
K080497 · FRO
Derma Sciences Canada, Inc.
General & Plastic Surgery · 126d
Cleared Jun 27, 2008
PRESSURE INJFECTABLE PICC
K080604 · LJS
Arrow International, Inc.
General Hospital · 115d
Cleared Jun 27, 2008
POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES
K080617 · HRX
Richard Wolf Medical Instruments Corp.
Orthopedic · 115d
Cleared Jun 27, 2008
MODIFICATION TO CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900
K080679 · KNT
Viasys Medsystems
Gastroenterology & Urology · 109d
Cleared Jun 27, 2008
INTEL HEALTH GUIDE, MODEL: PHS6000
K080798 · DRG
Intel Corp.
Cardiovascular · 99d
Cleared Jun 27, 2008
MOUNTAINEER OCT SPINAL SYSTEM
K080828 · MNH
Depuy Spine, Inc.
Orthopedic · 94d
Cleared Jun 27, 2008
ZEN PROGRAM (MIND 440 HEARING AID)
K080955 · KLW
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 85d
Cleared Jun 27, 2008
DORNIER MEDILAS D 30 LASER, MEDILAS D 1064
K080959 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 85d
Cleared Jun 27, 2008
GPS, G SURGICAL PEDICLE SYSTEM
K081041 · MNH
G Surgical Co., Ltd.
Orthopedic · 77d
Cleared Jun 27, 2008
FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12
K081049 · DRA
Cryocath Technologies, Inc.
Cardiovascular · 74d
Cleared Jun 27, 2008
BIOMET PHOENIX ANKLE NAIL SYSTEM
K081243 · HSB
Biomet Trauma
Orthopedic · 57d
Cleared Jun 27, 2008
HERO, VERSION 2.0
K081473 · DPS
Medical Predictive Science Corp.
Cardiovascular · 31d
Cleared Jun 27, 2008
MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM
K081542 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 25d
Cleared Jun 27, 2008
TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED
K081555 · HIL
Procter & Gamble Co.
Obstetrics & Gynecology · 24d
Cleared Jun 27, 2008
MEDTRONIC EXPORT AP CATHETER
K081573 · DXE
Medtronic Vascular
Cardiovascular · 22d
Cleared Jun 27, 2008
MILLENIUM II
K081665 · IOR
Next Mobility, LLC
Physical Medicine · 14d
Cleared Jun 26, 2008
S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST
K072142 · CKF
Alfa Wassermann Diagnostic...
Chemistry · 329d
Cleared Jun 26, 2008
CABS'AIR
K072962 · FTL
Cousin Biotech Sas
General & Plastic Surgery · 251d
Cleared Jun 26, 2008
S-TEST C02
K073223 · KHS
Alfa Wassermann Diagnostic...
Chemistry · 224d