FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
77881–77904 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 14, 2001
NORMED MANDIBULAR FIXATION SYSTEM
K010118 · JEY
Osteomedics, Inc.
Dental · 210d
Cleared Aug 14, 2001
DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC,...
K010399 · MSD
Diatek, Inc.
Gastroenterology & Urology · 186d
Cleared Aug 14, 2001
BAUMER LOCKING NAIL
K011504 · JDS
Baumer, S.A
Orthopedic · 90d
Cleared Aug 14, 2001
HCG STAT PAK ULTRA-FAST
K011550 · JHI
Chembio Diagnostic Systems, Inc.
Chemistry · 88d
Cleared Aug 14, 2001
SURE CHECK PREGNANCY TEST
K011551 · LCX
Chembio Diagnostic Systems, Inc.
Chemistry · 88d
Cleared Aug 14, 2001
MODEL 235GE-64
K011608 · MOS
Medical Advances, Inc.
Radiology · 81d
Cleared Aug 14, 2001
SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES
K011717 · LZA
Sunmax Enterprise Shanghai Co. , Ltd.
General Hospital · 71d
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