FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
125977–126000 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 03, 1990
BURNS CASUALTY SHEET LIMB WRAP
K900443 · FPY
Pilgrim Medical Services
General & Plastic Surgery · 154d
Cleared Jul 03, 1990
SEMPERMED SURGEON'S GLOVES
K900587 · KGO
Semperit Industrial Products
General Hospital · 146d
Cleared Jul 03, 1990
ATTEST BRAND RAPID READOUT BIOLOGICAL INDICATOR
K900771 · FRC
3M Company
General Hospital · 133d
Cleared Jul 03, 1990
MODIFIED MEDTRONIC CLASSIX MODEL 8438 PULSE GENE.
K901535 · DXY
Medtronic Vascular
Cardiovascular · 92d
Cleared Jul 03, 1990
GIOTTO MAMMOGRAPHY HF
K901558 · IZH
Medical Device Marketing Network, Inc.
Radiology · 91d
Cleared Jul 03, 1990
SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY.
K901624 · DTZ
Shiley, Inc.
Cardiovascular · 85d
Cleared Jul 03, 1990
GNOMOS STEREOTACTIC DEVICE
K901670 · HAW
Medical Equipment Development Co., Inc.
Neurology · 84d
Cleared Jul 03, 1990
PTI ANASTOMARK(TM) CORONARY BYPASS GRAFT MARKERS
K901682 · DSY
Pioneering Technologies, Inc.
Cardiovascular · 84d
Cleared Jul 03, 1990
MODIFIED TARGET THERAPEUTICS COILS
K901721 · HCG
Target Therapeutics
Neurology · 81d
Cleared Jul 03, 1990
CHEMOSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEM
K901722 · LJT
Device Labs, Inc.
General Hospital · 78d
Cleared Jul 03, 1990
SONOCA II ULTRASONIC SURGICAL DEVICE
K901737 · LFL
Holl Meditronics, Inc.
General & Plastic Surgery · 77d
Cleared Jul 03, 1990
DOBBHOFF(R) RETRIEVAL FORCEPS
K901744 · KQW
Biosearch Medical Products, Inc.
Neurology · 77d
Cleared Jul 03, 1990
CHALLENGE 5000 POWERED MUSCLE STIMULATOR
K901768 · IPF
Maximum Performance Technologies,...
Physical Medicine · 76d
Cleared Jul 03, 1990
CHALLENGE 6000 POWERED MUSCLE STIMULATOR
K901769 · IPF
Maximum Performance Technologies,...
Physical Medicine · 76d
Cleared Jul 03, 1990
CHALLENGE 7000 POWERED MUSCLE STIMULATOR
K901770 · IPF
Maximum Performance Technologies,...
Physical Medicine · 76d
Cleared Jul 03, 1990
MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY
K901815 · DRE
Pioneering Technologies, Inc.
Cardiovascular · 71d
Cleared Jul 03, 1990
PLUS TOTAL KNEE SYST/PERI POST DESIGN TIBIAL COMP
K901936 · JWH
Orthomet, Inc.
Orthopedic · 64d
Cleared Jul 03, 1990
CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL
K902081 · JBP
Hemotec, Inc.
Hematology · 56d
Cleared Jul 03, 1990
THROMBOPLASTIN WITH CALCIUM
K902096 · GJS
Sigma Chemical Co.
Hematology · 56d
Cleared Jul 03, 1990
MINIX, MINIX ST, NEW IC: L74
K902134 · DXY
Medtronic Vascular
Cardiovascular · 54d
Cleared Jul 03, 1990
ORTHOKROME NORMAL AND ABNORMAL CONTROL PLASMA
K902210 · GGN
Ortho Diagnostic Systems, Inc.
Hematology · 48d
Cleared Jul 03, 1990
ACCUSCAN MICROBEAD STANDARDS
K902294 · JIW
Sigma Chemical Co.
Hematology · 42d
Cleared Jul 03, 1990
NEW LENGTH SUGITA APPLIERS
K902516 · HIC
Sims Surgical, Inc.
Obstetrics & Gynecology · 26d
Cleared Jul 03, 1990
NEUROSURGICAL HEADFRAME ACCESSORIES
K902517 · GZT
Sims Surgical, Inc.
Neurology · 26d