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
65881–65904 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 23, 2005
INTEGRA IMMOBILIZATION SYSTEM
K050888 · IYE
Diacor, Inc.
Radiology · 46d
Cleared May 23, 2005
GE VIEWPOINT
K050943 · LLZ
General Electric Co.
Radiology · 39d
Cleared May 23, 2005
VITEK 2 GRAM POSITIVE TRIMETHOPRIM/SULFAMETHOXAZOLE
K050976 · LON
bioMerieux, Inc.
Microbiology · 35d
Cleared May 23, 2005
TITANIUM-HIP TOOL
K051032 · HRS
Orthopedic Sciences, Inc.
Orthopedic · 31d
Cleared May 23, 2005
INTRABEAM SYSTEM
K051055 · JAD
Carl Zeiss Surgical GmbH
Radiology · 27d
Cleared May 23, 2005
POLYAXIAL HEMISPHERICAL SPINAL SCREWS
K051063 · MNI
Scient'X
Orthopedic · 27d
Cleared May 23, 2005
GEMINI GXL
K051170 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 17d
Cleared May 23, 2005
CUSTOM-HIP TOOL
K051181 · HRS
Orthopedic Sciences, Inc.
Orthopedic · 14d
Cleared May 20, 2005
WIMRT MODULE FOR ARTP PLANNING SYSTEM
K041971 · MUJ
Prodigm Group, Inc.
Radiology · 302d
Cleared May 20, 2005
ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM
K043197 · CGA
Lifescan, Inc.
Chemistry · 183d
Cleared May 20, 2005
XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
K050534 · FGE
Abbott Laboratories
Gastroenterology & Urology · 79d
Cleared May 20, 2005
ACON +/- MIDSTREAM PREGNANCY TEST
K050546 · LCX
ACON Laboratories, Inc.
Chemistry · 79d
Cleared May 20, 2005
MOTIFMESH SOFT TISSUE PATCH
K050678 · FTL
Proxy Biomedical , Ltd.
General & Plastic Surgery · 65d
Cleared May 20, 2005
ATLANTIS PV
K050684 · DQO
Boston Scientific Corp
Radiology · 64d
Cleared May 20, 2005
ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011
K050748 · CKG
Scantibodies Laboratory, Inc.
Chemistry · 59d
Cleared May 20, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TRIMETHOPRIM-SULFAMETHOXAZOLE...
K050865 · LON
Becton, Dickinson & CO
Microbiology · 45d
Cleared May 20, 2005
THE HERMES SYSTEM
K050929 · DRG
Palaistra Systems, Inc.
Cardiovascular · 36d
Cleared May 20, 2005
GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN
K050963 · MOT
Mds Nordion
Radiology · 32d
Cleared May 20, 2005
D731 MICRO 20 PH.I.S.I.O PEDIATRIC ARTERIAL FILTER, D733 MICRO 40 PH.I.SI.O...
K051232 · DTM
Dideco S.R.L.
Cardiovascular · 7d
Cleared May 19, 2005
ENPATH DEFLECTABLE CATHETER
K043489 · DQY
Enpath Medical Incorporated
Cardiovascular · 153d
Cleared May 19, 2005
SIS DERMAL AUGMENTATION STRAND
K050246 · FTM
Cook Biotech, Inc.
General & Plastic Surgery · 106d
Cleared May 19, 2005
POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET,PINK,GREEN,BLACK)
K050528 · LZA
Spi Gloves Sdn. Bhd.
General Hospital · 78d
Cleared May 19, 2005
TIUNITE IMPLANTS
K050705 · DZE
Nobel Biocare AB
Dental · 62d
Cleared May 19, 2005
SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM
K050731 · MWJ
Ge Medical Systems Information...
Cardiovascular · 59d