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
159313–159336 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 16, 1982
NEEDLE HOLDERS
K822197 · LCR
Kelleher Corp.
Toxicology · 24d
Cleared Aug 16, 1982
TOTAL IGE DISCS
K822206 · DGC
Kallestad Laboratories, Inc.
Chemistry · 21d
Cleared Aug 16, 1982
STERILE HD PAN SET
K822211 · FRG
Hospital Disposables, Inc.
General Hospital · 21d
Cleared Aug 16, 1982
VOLUMETRIC CONTROLLER
K822216 · BTC
Quest Medical, Inc.
Anesthesiology · 21d
Cleared Aug 16, 1982
EMPI SINGLE USE
K822224 · GXY
Empi
Neurology · 20d
Cleared Aug 16, 1982
ERIKA NEGAT. PRESSURE ARTER. BLOOD LINE
K822225 · KOC
Erika, Inc.
Gastroenterology & Urology · 20d
Cleared Aug 16, 1982
ERIKA NEGATIVE PRESSURE VENOUS BLOOD LIN
K822226 · KOC
Erika, Inc.
Gastroenterology & Urology · 20d
Cleared Aug 16, 1982
IMMO PHASE FSH RADIOIMMUNOASSAY
K822227 · CGJ
Corning Medical & Scientific
Chemistry · 20d
Cleared Aug 16, 1982
ACA URINARY PROTEIN CALIBRATOR
K822232 · JIS
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 20d
Cleared Aug 16, 1982
UREA NITROGEN REAGENT SET (MOD. BERTHEL
K822237 · CDL
Sterling Biochemical, Inc.
Chemistry · 19d
Cleared Aug 16, 1982
VARIOUS TYPES OF TONSILS HEMOSTATS
K822263 · HRQ
Kelleher Corp.
General & Plastic Surgery · 18d
Cleared Aug 16, 1982
NAGASHIMA KN-52 SACCADE & PURSUIT STIM
K822266 · GWN
Kelleher Corp.
Neurology · 18d
Cleared Aug 16, 1982
VARIOUS TYPES OF ENT ELEVATORS
K822270 · KAD
Kelleher Corp.
Ear, Nose, Throat · 18d
Cleared Aug 16, 1982
VANCOMYCIN FLUORESCENT IMMUNOASSAY
K822308 · LEH
American Diagnostic Corp.
Toxicology · 13d
Cleared Aug 16, 1982
C-REACTIVE PROTEIN TEST KIT
K822332 · JIS
Sclavo, Inc.
Chemistry · 12d
Cleared Aug 16, 1982
HEMATOXYLIN STAIN SOLUTION
K822352 · HYJ
Fisher Scientific Co., LLC
Pathology · 10d
Cleared Aug 16, 1982
DIANEAL SOLUTION EXCHANGE DEVICE #5C4193
K822361 · FKX
Travenol Laboratories, S.A.
Gastroenterology & Urology · 10d
Cleared Aug 16, 1982
SONOLINE 1000, 8008 AND 8080
K827503
Siemens Medical Solutions USA, Inc.
Radiology · 18d
Cleared Aug 16, 1982
DIASONICS CARDIO/IMAGING ECHOSCOPE
K827573
Diasonics, Inc.
Radiology · 24d
Cleared Aug 16, 1982
AUTO-TECH GENERATOR
K827662
Bennett X-Ray Corp.
Radiology · 47d
Cleared Aug 16, 1982
SINUSON 810 ULTRASOUND SCANNER
K827663
Am Labs, Inc.
Radiology · 47d
Cleared Aug 16, 1982
LIGHT PEN ACCESSORY FOR USE WITH FETASCAN 800 SERIES
K827712
Cranston Medical Laboratory
Radiology · 55d
Cleared Aug 16, 1982
UNKNOWN
K827718
Cranbury Medical Labs, Inc.
Radiology · 55d
Cleared Aug 16, 1982
THYRO-COUNT THYROID UPTAKE SYSTEM 90IZD PROBE
K827748
Kemble Instruments, Inc.
Radiology · 27d