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
78865–78888 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 28, 2001
TRULINE INFUSION CATHETERS
K011937 · FOZ
Micro Therapeutics, Inc.
General Hospital · 68d
Cleared Aug 28, 2001
BI-PHASIC INFILTRATOR
K012044 · FRN
Reliance Medical Corp.
General Hospital · 60d
Cleared Aug 28, 2001
ATTAIN ACCESS 6218 LEFT-HEART DELIVERY SYSTEM, MODEL 6218
K012083 · DQY
Medtronic Vascular
Cardiovascular · 56d
Cleared Aug 28, 2001
ATTAIN LDS 6216 LEFT-HEART DELIVERY SYSTEM
K012130 · DQY
Medtronic Vascular
Cardiovascular · 50d
Cleared Aug 28, 2001
ATTAIN 6215 VENOGRAM BALLOON CATHETER
K012225 · DYG
Medtronic Vascular
Cardiovascular · 43d
Cleared Aug 28, 2001
WH ACCU TEST PREGNANCY TEST
K012284 · JHI
W.H.P.M., Inc.
Chemistry · 39d
Cleared Aug 28, 2001
COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MULTI ANALYTE...
K012431 · JJY
Bionostics, Inc.
Chemistry · 28d
Cleared Aug 27, 2001
SIOS-INTERFACE FOR AUTO LIGHT PROJECTOR, SIOS-INTERFACE FOR 3 CCD ENDOCAM,...
K002328 · HIF
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 391d
Cleared Aug 27, 2001
PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM
K010411 · FGE
Cordis Corp.
Gastroenterology & Urology · 196d
Cleared Aug 27, 2001
NEUROEDGE INFUSION CATHETER
K011646 · KRA
Neuro Vasx, Inc.
Cardiovascular · 90d
Cleared Aug 27, 2001
HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR
K011657 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 90d
Cleared Aug 27, 2001
GPW-SF
K011659 · EJT
Gateway Alloys, Inc.
Dental · 90d
Cleared Aug 27, 2001
CONCORD 88
K011661 · EJT
Gateway Alloys, Inc.
Dental · 90d
Cleared Aug 27, 2001
MACROPORE IB RESORBABLE PLUG
K011715 · JDI
Macropore Biosurgery, Inc.
Orthopedic · 84d
Cleared Aug 27, 2001
OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC...
K011886 · ODG
Olympus America, Inc.
Radiology · 73d
Cleared Aug 27, 2001
DIRECT BILIRUBIN REAGENT
K011972 · CIG
Intersect Systems, Inc.
Chemistry · 63d
Cleared Aug 27, 2001
DRI ECSTASY URINE CALIBRATORS
K012109 · DLJ
Microgenics Corp.
Toxicology · 52d
Cleared Aug 27, 2001
DRI ECSTASY ENZYME IMMUNOASSAY
K012110 · DKZ
Microgenics Corp.
Toxicology · 52d
Cleared Aug 27, 2001
ERIS LAYERING MATERIALS
K012174 · EIH
Ivoclar North America, Inc.
Dental · 46d
Cleared Aug 27, 2001
CLAY-PARK LABS, INC. - LUBRICATING JELLY
K012203 · NUC
Clay-Park Labs, Inc.
Obstetrics & Gynecology · 45d
Cleared Aug 27, 2001
TAO EMBRYO TRANSFER CATHETER SYSTEM
K012220 · MQF
Ttj Biomedical, LLC
Obstetrics & Gynecology · 42d
Cleared Aug 27, 2001
POINT 4 FLOWABLE
K012321 · EBF
Sybron Dental Specialties, Inc.
Dental · 35d
Cleared Aug 27, 2001
MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3
K012430 · JJX
Bionostics, Inc.
Chemistry · 27d
Cleared Aug 27, 2001
TERUMO 30 GAUGE HYPODERMIC NEEDLE
K012646 · FMI
Terumo Medical Corp.
General Hospital · 14d