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
169465–169488 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 10, 1979
DEVELOPMENT NO. 647
K790414 · EJT
Deringer-Ney, Inc.
Dental · 43d
Cleared Apr 10, 1979
DIATEK 500
K790416 · FLL
Diatek, Inc.
General Hospital · 41d
Cleared Apr 10, 1979
COLORANT
K790438 · EBD
Vivadent (Usa), Inc.
Dental · 34d
Cleared Apr 10, 1979
CONTACT RESIN
K790439 · EBF
Vivadent (Usa), Inc.
Dental · 34d
Cleared Apr 10, 1979
BACTERIOLOGICAL CULTURE MEDIA
K790497 · JSG
Micro Media Laboratories
Microbiology · 28d
Cleared Apr 10, 1979
PEDIATRIC OSTEOTOMY SYSTEM
K790501 · KTT
Howmedica Corp.
Orthopedic · 28d
Cleared Apr 10, 1979
TRAPEZIO-METACARPAL JOINT SPACER
K790508 · KYI
Scientific Data Systems Israel, Ltd.
Orthopedic · 32d
Cleared Apr 10, 1979
OREIA - DIGOXIN
K790521 · KXT
Organon, Inc.
Toxicology · 25d
Cleared Apr 10, 1979
HEARING AID DANAVOX 775V
K790539 · ESD
Danavox, Inc.
Ear, Nose, Throat · 21d
Cleared Apr 10, 1979
EXETER LIP SEAL
K790554 · LFA
Exeter Medical Labs, Inc.
Ear, Nose, Throat · 22d
Cleared Apr 10, 1979
ROLLCHAIR, ORTHO BUCKET SEAT
K790560 · INM
Maddak, Inc.
Physical Medicine · 22d
Cleared Apr 10, 1979
LOUNGE, TILT-A-BODY STRETCH
K790572 · ION
Innovative Products, Inc.
Physical Medicine · 18d
Cleared Apr 10, 1979
AUDIOMETER
K790609 · EWO
Grason-Stadler, Inc.
Ear, Nose, Throat · 12d
Cleared Apr 10, 1979
IMPERVIOUS STERILE STOCKINETTE
K790634 · KKX
Anago, Inc.
General Hospital · 7d
Cleared Apr 10, 1979
MODEL WC-3 HEARING AID
K790651 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 7d
Cleared Apr 09, 1979
DAISCOPE & ACCESSORIES
K790506 · DRT
Simonsen & Weels Eftf.
Cardiovascular · 27d
Cleared Apr 06, 1979
PILLOW, CARTER ARM ELEVATION
K790283 · KME
Depuy, Inc.
General Hospital · 52d
Cleared Apr 06, 1979
NOVATEC PRM
K790450 · JOM
Novatec, Inc.
Cardiovascular · 32d
Cleared Apr 05, 1979
DYONICS STEROTOXIC POSITIONER
K790502 · HAW
Dyonics, Inc.
Neurology · 23d
Cleared Apr 04, 1979
KNEE SYSTEM, QUADRAXIAL CONSTRAINED
K781971 · KRO
Hexcel Medical
Orthopedic · 128d
Cleared Apr 04, 1979
PREGNANCY, SENSIDEX TUBE TEST
K782063 · JHJ
Ortho Diagnostics, Inc.
Chemistry · 114d
Cleared Apr 04, 1979
SLIDE TEST FOR PREGNANCY, GRAVINDEX 90
K782166 · JHJ
Ortho Diagnostics, Inc.
Chemistry · 96d
Cleared Apr 04, 1979
ATOMIZER, FURNACE MODEL HGA-400
K790111 · JXR
The Perkin-Elmer Corp.
Toxicology · 76d
Cleared Apr 04, 1979
STANDARD PECTORALIS MUSCLE IMPLANT
K790245
Medical Engineering Corp.
General & Plastic Surgery · 57d