FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
78409–78432 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 10, 2001
ROSS EMBRACE PUMP SET
K011467 · KNT
Ross Products
Gastroenterology & Urology · 88d
Cleared Aug 10, 2001
POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL...
K011472 · FFX
Medtronic Functional Diagnostics A/S
Gastroenterology & Urology · 88d
Cleared Aug 10, 2001
OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1
K011484 · FBK
Olympus Optical Co., Ltd.
Gastroenterology & Urology · 88d
Cleared Aug 10, 2001
CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS,...
K011496 · FBO
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 87d
Cleared Aug 10, 2001
MP3U, POWER WHEELCHAIR
K011513 · ITI
Merits Health Products., Inc.
Physical Medicine · 86d
Cleared Aug 10, 2001
SPERMCATCH
K011607 · MQL
Nidacon International AB
Obstetrics & Gynecology · 78d
Cleared Aug 10, 2001
KOALA CLAMP, KOALA CLAMP AND CUTTER
K011621 · HFW
Maternus, Inc.
Obstetrics & Gynecology · 77d
Cleared Aug 10, 2001
CERVILENZ UTERINE MEASURING SOUND
K011840 · HHM
Cervilenz, Inc.
Obstetrics & Gynecology · 59d