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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
165985–166008 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 07, 1980
ELECTROCARDIOGRAPH, MODEL ECG-5503
K801677 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 16d
Cleared Aug 07, 1980
MODEL BP-200 INFANT PRESSURE VENTILATOR
K801697 · CBK
Bourns Medical Systems, Inc.
Anesthesiology · 15d
Cleared Aug 07, 1980
UNI-RECORD I
K801700 · DXH
Bd Becton Dickinson Vacutainer...
Cardiovascular · 14d
Cleared Aug 07, 1980
BAUER & BLACK RIGID WRIST BRACE
K801701 · IQI
Bd Becton Dickinson Vacutainer...
Physical Medicine · 14d
Cleared Aug 07, 1980
BK-1424 INNER LIP PLATE, CERAMIC
K801705 · ILC
Fred Sammons, Inc.
Physical Medicine · 14d
Cleared Aug 07, 1980
BK-1426-00-01 STONYBROOK/HI-WALL PLATE
K801706 · ILC
Fred Sammons, Inc.
Physical Medicine · 14d
Cleared Aug 07, 1980
BK-1520-01 ECONOMY WRIST SUPPORT, CHILD
K801708 · IQI
Fred Sammons, Inc.
Physical Medicine · 14d
Cleared Aug 07, 1980
BK-5058-01 QUAD-QUIP WHEELCHAIR CUFF
K801709 · KNO
Fred Sammons, Inc.
Physical Medicine · 14d
Cleared Aug 07, 1980
BK-5315-01 FOAM HAND EXERCISER, SMALL
K801710 · ION
Fred Sammons, Inc.
Physical Medicine · 14d
Cleared Aug 07, 1980
LUMBOSACRAL SUPPORTS & THORACO-LUMBO-SAC
K801712 · IPY
Fred Sammons, Inc.
Physical Medicine · 14d
Cleared Aug 07, 1980
BK-6157-02 C.V.A SLING, MEDIUM&LARGE
K801713 · ILI
Fred Sammons, Inc.
Physical Medicine · 14d
Cleared Aug 07, 1980
TRANS DISTAL JOINT FINGER EXTEN. SPLINT
K801714 · ILH
Fred Sammons, Inc.
Physical Medicine · 14d
Cleared Aug 07, 1980
CURITY PARACERVICAL/PUDENDAL BLOCK ANES
K801724 · CAZ
The Kendal Co.
Anesthesiology · 14d
Cleared Aug 07, 1980
PRISMA-FIL
K801732 · EBF
Dentsply Intl.
Dental · 13d
Cleared Aug 07, 1980
PLASTAZOTE SHOE
K801743 · KNP
Alimed, Inc.
Physical Medicine · 10d
Cleared Aug 07, 1980
ARTERIAL BUBBLE TRAP
K801770 · DWF
Delta Medical Industries
Cardiovascular · 10d
Cleared Aug 07, 1980
COLD PACK #589
K801776 · IME
Sunbeam Corp.
Physical Medicine · 10d
Cleared Aug 07, 1980
OXYDENTAL ZINC OXIDE EUGENOL(ZOE)CEMENT
K801779 · EMB
Oxy Dental Products, Inc.
Dental · 10d
Cleared Aug 07, 1980
OXY CUSTOM TRAY RESIN
K801780 · EBH
Oxy Dental Products, Inc.
Dental · 10d
Cleared Aug 07, 1980
HUMEROUS FRACTURE BRACE, ULNA FRACTURE
K801788 · IQI
Hosmer Dorrance Corp.
Physical Medicine · 9d
Cleared Aug 07, 1980
SCI-PHARM PAINT-ON RESTORATIVE
K801797 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 9d
Cleared Aug 07, 1980
COMPOSITE RESTORATIVE, PASTE/PASTE TYPE
K801798 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 9d
Cleared Aug 04, 1980
DEBRISAN (DEXTRANOMER) PASTE
K800737 · KOZ
Pharmaseal Laboratories
General & Plastic Surgery · 124d
Cleared Aug 04, 1980
WEBER-MAYO WRIST
K801157 · KWM
Depuy, Inc.
Orthopedic · 82d