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
61993–62016 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 11, 2006
EBI, L.P.'S LINE EXTENSION TO THE ARRAY SPINAL SYSTEM
K061978 · MNI
Ebi, L.P.
Orthopedic · 29d
Cleared Aug 11, 2006
WEB VIEWER, POCKET VIEWER AND CELLULAR VIEWER WITH L- WEB05 SOFTWARE
K061994 · MSX
Ge Healthcare
Cardiovascular · 28d
Cleared Aug 11, 2006
SPIDERX EMBOLIC PROTECTION DEVICE
K062201 · NFA
Ev3, Inc.
Cardiovascular · 10d
Cleared Aug 11, 2006
MODIFICATION TO GUARDDOG OCCLUSION SYSTEM
K062220 · MJN
Possis Medical, Inc.
Cardiovascular · 9d
Cleared Aug 10, 2006
ENZY-WELL SYPHILIS IGG, MODEL 91106
K050590 · LIP
Diesse Diagnostica Senese S.P.A.
Microbiology · 520d
Cleared Aug 10, 2006
COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
K053287 · MKZ
Roche Diagnostics Corp.
Microbiology · 258d
Cleared Aug 10, 2006
COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
K053289 · LSL
Roche Diagnostics Corp.
Microbiology · 258d
Cleared Aug 10, 2006
EASYSPINE SYSTEM
K061017 · MNI
Ldr Spine USA
Orthopedic · 119d
Cleared Aug 10, 2006
DM-3000 DIGITAL BLOOD PRESSURE MONITOR
K061086 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 114d
Cleared Aug 10, 2006
VOLCANO S51 FAMILY OF IMAGING SYSTEMS
K061215 · IYO
Volcano Corporation
Radiology · 100d
Cleared Aug 10, 2006
BLUESKY VISTA WOUND VACUUM SYSTEM, MODEL 100.0500
K061367 · OMP
Blue Sky Medical Group Incorporated
General & Plastic Surgery · 86d
Cleared Aug 10, 2006
PUREWRIST SCISSORS, MODEL PW1101-01
K061425 · GEI
Cambridge Endoscopic Devices
General & Plastic Surgery · 79d
Cleared Aug 10, 2006
KNEE FUSION NAIL
K061783 · JDS
Smith & Nephew, Inc.
Orthopedic · 45d
Cleared Aug 10, 2006
LATERAL PLATE SYSTEM
K061789 · KWQ
Nuvasive, Inc.
Orthopedic · 45d
Cleared Aug 10, 2006
NEUROQUANT
K061855 · LLZ
Cortechs Labs, Inc.
Radiology · 41d
Cleared Aug 10, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFAZOLIN (GN) 0.5-32 UG/ML
K061867 · LON
Becton, Dickinson & CO
Microbiology · 38d
Cleared Aug 10, 2006
PLASMASEAL OPEN FORCEPS, MODELS 2103PK AND 91701PK
K061975 · GEI
Acmi Corporation
General & Plastic Surgery · 28d
Cleared Aug 10, 2006
VITAL CONNECT 4.0
K062154 · LLZ
Vital Images, Inc.
Radiology · 13d
Cleared Aug 09, 2006
CARDIODRIVE, MODEL 001-004115 (NON-STERILE)
K042850 · DQY
Stereotaxis, Inc.
Cardiovascular · 663d
Cleared Aug 09, 2006
TENOLIG
K060367 · GAT
Fournitures Hospitalieres Industrie
General & Plastic Surgery · 177d
Cleared Aug 09, 2006
POWERHICKMAN LONG-TERM INTRAVASCULAR CATHETER
K061179 · LJS
C.R. Bard, Inc.
General Hospital · 104d
Cleared Aug 09, 2006
ENHANCE DENTAL IMPLANT SYSTEM
K061335 · DZE
Coastal Biocare
Dental · 89d
Cleared Aug 09, 2006
LAC-MAC INNERBLOC O.R. GOWN
K061491 · FYA
Lac Mac, Ltd.
General Hospital · 70d
Cleared Aug 09, 2006
KENDALL ARGYLE NEONATAL/PEDIATRIC PICC, MODEL 43311
K061936 · LJS
The Kendall Company
General Hospital · 30d