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
79009–79032 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 14, 2001
ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES
K011721 · KGO
Allegiance Healthcare Corp.
General Hospital · 71d
Cleared Aug 14, 2001
CORERESTORE 2
K011798 · EBF
Sybron Dental Specialties, Inc.
Dental · 67d
Cleared Aug 14, 2001
FHC MICROTARGETING DRIVE SYSTEM
K011992 · HAW
FHC, Inc.
Neurology · 49d
Cleared Aug 14, 2001
CG-3250 MINIRECEIVER
K012187 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 33d
Cleared Aug 14, 2001
MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID)
K012289 · IYE
Elekta Oncology Systems, Ltd.
Radiology · 25d
Cleared Aug 14, 2001
HNC-127 NEUROVASCULAR ARRAY COIL
K012353 · MOS
Mri Devices Corp.
Radiology · 20d
Cleared Aug 14, 2001
PACEART TX3 CARDIAC EVENT RECORDER
K012407 · DXH
Paceart, Inc.
Cardiovascular · 15d
Cleared Aug 14, 2001
MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD
K012452 · LDF
Medtronic Vascular
Cardiovascular · 13d
Cleared Aug 14, 2001
MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD
K012454 · LDF
Medtronic Vascular
Cardiovascular · 13d
Cleared Aug 14, 2001
MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD
K012458 · LDF
Medtronic Vascular
Cardiovascular · 13d
Cleared Aug 14, 2001
MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE
K012459 · LDF
Medtronic Vascular
Cardiovascular · 13d
Cleared Aug 14, 2001
MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD
K012460 · LDF
Medtronic Vascular
Cardiovascular · 13d
Cleared Aug 13, 2001
COOK ZILVER BILIARY STENT
K010242 · FGE
Cook, Inc.
Gastroenterology & Urology · 200d
Cleared Aug 13, 2001
OSMED TISSUE EXPANDER
K010852 · NFM
Iop, Inc.
Ophthalmic · 145d
Cleared Aug 13, 2001
INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS
K011184 · FGE
Intratherapeutics, Inc.
Gastroenterology & Urology · 117d
Cleared Aug 13, 2001
INSTRUMENTS FOR ONE TIME USE - DISPOSABLE
K011514 · KDD
Kencap , Ltd.
General & Plastic Surgery · 88d
Cleared Aug 13, 2001
EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID...
K011878 · DKJ
Syva Co.
Toxicology · 59d
Cleared Aug 13, 2001
BACK-UP MEIER GUIDEWIRE
K011906 · DQX
Boston Scientific Corp
Cardiovascular · 55d
Cleared Aug 13, 2001
GULLIVER AND CLASSE A
K012213 · EIA
American Dental Technologies, Inc.
Dental · 28d
Cleared Aug 10, 2001
SMARTWAVE IF 2000
K003631 · LIH
Newwave Medical, LLC
Neurology · 259d
Cleared Aug 10, 2001
QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD...
K010039 · NBW
Chronimed, Inc.
Chemistry · 217d
Cleared Aug 10, 2001
VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE
K010544 · DYH
Apex Dental Materials, Inc.
Dental · 168d
Cleared Aug 10, 2001
CYBERKNIFE SYSTEM
K011024 · IYE
Accuray, Inc.
Radiology · 128d
Cleared Aug 10, 2001
REUSABLE GLASS SYRINGES
K011176 · FMF
Lockett Medical Corp.
General Hospital · 115d