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
159241–159264 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 24, 1982
IMMU-COUNT 404
K822293 · JJJ
Kemble Instruments, Inc.
Chemistry · 22d
Cleared Aug 24, 1982
PROCEDURE #430 & REAGENTS FOR ACETAMIN
K822313 · LDP
Sigma Chemical Co.
Chemistry · 21d
Cleared Aug 24, 1982
SWAN-GANZ FLOW-DIRECTED THERMODIL. CATH
K822350 · DYG
American Edwards Laboratories
Cardiovascular · 18d
Cleared Aug 24, 1982
TENS ELECTRODE
K822378 · GXY
Franklin Sales & Mfg. Co.
Neurology · 18d
Cleared Aug 24, 1982
LIFE TRACE 14
K822388 · DRT
Life Science Instrumentation, Inc.
Cardiovascular · 15d
Cleared Aug 24, 1982
INNOSCAN EXAMINATION LIGHT
K827796
Innomed Corp.
Radiology · 26d
Cleared Aug 24, 1982
SONOLINE 6000
K827815
Siemens Medical Solutions USA, Inc.
Radiology · 27d
Cleared Aug 24, 1982
PODIATRY X-RAY UNIT
K827816
The S. S. White Co.
Radiology · 29d
Cleared Aug 24, 1982
MODEL 835 SPOT FILM DEVICE
K827858
General Electric Co.
Radiology · 15d
Cleared Aug 23, 1982
FOLDALITE UNIT
K827890 · FTC
National Biological Corp.
Radiology · 12d
Cleared Aug 20, 1982
PROXIMATE DISPOSABLE SKIN STAPLERS
K820811 · GAG
Ethicon, Inc.
General & Plastic Surgery · 150d
Cleared Aug 20, 1982
POROCOAT LOW PROFILE METAL BACKED CUP
K821713 · JDI
Depuy, Inc.
Orthopedic · 71d
Cleared Aug 20, 1982
POROCOAT STANDARD METAL BACKED CUP
K821714 · JDI
Depuy, Inc.
Orthopedic · 71d
Cleared Aug 20, 1982
PIGTAIL STENTS
K821819 · FGE
American Endoscopy, Inc.
Gastroenterology & Urology · 60d
Cleared Aug 20, 1982
BT 794-BLOOD/FLUID WARMER
K822098 · LGZ
Electromedics, Inc.
General Hospital · 35d
Cleared Aug 20, 1982
LENS EASY ON
K822105 · HPX
L.E.O. Corp.
Ophthalmic · 31d
Cleared Aug 20, 1982
MICROSURGICAL EAR HOOK
K822166 · JYL
Kelleher Corp.
Ear, Nose, Throat · 28d
Cleared Aug 20, 1982
STILL ENDOSCOPIC CAMERAS
K822167 · FXM
Kelleher Corp.
General & Plastic Surgery · 28d
Cleared Aug 20, 1982
SURGICAL HEAD SUPPORT
K822169 · HBM
Kelleher Corp.
Neurology · 28d
Cleared Aug 20, 1982
ADAPTOR FOR FIBEROPTIC LIGHT SOURCE
K822175 · EQH
Kelleher Corp.
Ear, Nose, Throat · 28d
Cleared Aug 20, 1982
RIGID FIBEROPTIC ENDOSCOPES
K822180 · EOQ
Kelleher Corp.
Ear, Nose, Throat · 28d
Cleared Aug 20, 1982
HEAD MIRROR WITH HEADBAND
K822191 · KAI
Kelleher Corp.
Ear, Nose, Throat · 28d
Cleared Aug 20, 1982
FIBEROPTIC LIGHT CARRIERS
K822192 · EQH
Kelleher Corp.
Ear, Nose, Throat · 28d
Cleared Aug 20, 1982
KNIFE HANDLE
K822203 · KTG
Kelleher Corp.
Ear, Nose, Throat · 28d