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

Filters: Cleared only ×
176,076 results
63265–63288 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 28, 2006
ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800
K060543 · NUA
Clinical Micro Sensors, Inc.
Pathology · 27d
Cleared Mar 27, 2006
TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM
K060120 · CDQ
Teco Diagnostics
Chemistry · 69d
Cleared Mar 27, 2006
ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY
K060306 · NUN
Isotis NV
Dental · 48d
Cleared Mar 24, 2006
FIXATURE MICROTHREAD OSSEOSPEED, A COMPONENT OF THE ASTRA TECH IMPLANT SYSTEM
K053384 · DZE
Astra Tech, Inc.
Dental · 109d
Cleared Mar 24, 2006
SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS
K053401 · CIC
Arkray, Inc.
Chemistry · 108d
Cleared Mar 24, 2006
VERIFY 3-10 MIN FLASH INTEGRATOR
K060066 · JOJ
Albert Browne , Ltd.
General Hospital · 74d
Cleared Mar 24, 2006
ISIGHT IMAGING CATHETER, MODEL 38986
K060175 · DQO
Boston Scientific Corp
Cardiovascular · 60d
Cleared Mar 24, 2006
ALBU TROL, LOW, MODEL 108.001.002
K060215 · JJX
Eurotrol B.V.
Chemistry · 56d
Cleared Mar 24, 2006
TITAN GUIDEWIRE
K060454 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 30d
Cleared Mar 24, 2006
THE PHILIPS MP20,MP30,MP40,MP50,MP60,MP70,MP80 AND MP90 INTELLIVUE ATIENT...
K060541 · MHX
Philips Medizin Systeme Boblingen GmbH
Cardiovascular · 23d
Cleared Mar 23, 2006
HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM
K052891 · HNO
Hawken Industries
Ophthalmic · 161d
Cleared Mar 23, 2006
IPLAN FLOW
K053164 · HAW
Brainlab AG
Neurology · 129d
Cleared Mar 23, 2006
MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS
K053229 · CAW
Merits Health Products Co., Ltd.
Anesthesiology · 125d
Cleared Mar 23, 2006
AEROLIFE ULTRASONIC NEBULIZER, MODEL P2C
K053360 · CAF
Aerovectrx Corporation
Anesthesiology · 111d
Cleared Mar 23, 2006
OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE
K053494 · MQL
Fertipro NV
Obstetrics & Gynecology · 98d
Cleared Mar 23, 2006
BD AUTOSHIELD PEN NEEDLE
K060007 · FMI
Becton, Dickinson & CO
General Hospital · 79d
Cleared Mar 23, 2006
KHAN KINETIC TREATMENT DEVICE (KKT-M1)
K060043 · LXM
Optima Health Solutions...
Physical Medicine · 76d
Cleared Mar 23, 2006
DOPPLEX CENTRALE
K060230 · HGM
Huntleigh Healthcare , Ltd.
Obstetrics & Gynecology · 52d
Cleared Mar 23, 2006
PALOMAR LUX1540 HANDPIECE
K060301 · GEX
Palomar Medical Technologies, Inc.
General & Plastic Surgery · 45d
Cleared Mar 23, 2006
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH VANCOMYCIN...
K060312 · LON
Dade Behring, Inc.
Microbiology · 43d
Cleared Mar 23, 2006
CYCLONE, MODEL MAICAM 180
K060486 · KPS
Spectrica
Radiology · 27d
Cleared Mar 23, 2006
LIFESTENT FLEXSTAR XL BILIARY STENT SYSTEM
K060487 · FGE
Edwards Lifesciences, LLC
Gastroenterology & Urology · 27d
Cleared Mar 23, 2006
DEPUY PFC SIGMA KNEE PROSTHESIS
K060515 · JWH
DePuy Orthopaedics, Inc.
Orthopedic · 24d
Cleared Mar 22, 2006
SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEM
K051510 · MBH
Signal Medical Corp.
Orthopedic · 288d