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
116977–117000 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 09, 1992
ULTRADENT PRODUCT PIT & FISSURE SEALANT PROD LINE
K921598 · EBF
Ultradent Products, Inc.
Dental · 159d
Cleared Sep 09, 1992
ULTRADENT PRODUCT TOOTH SURFACE DRYING AGENT
K921602 · EBF
Ultradent Products, Inc.
Dental · 159d
Cleared Sep 09, 1992
MADAVAC 190
K921611 · BTA
Mada Medical Products, Inc.
General & Plastic Surgery · 159d
Cleared Sep 09, 1992
TURN EZ BED DEVICE
K922473 · IKZ
Med-Ez, Inc.
Physical Medicine · 106d
Cleared Sep 09, 1992
DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH CALIBRATOR
K922698 · JIS
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 97d
Cleared Sep 09, 1992
DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH METHOD
K922701 · JLW
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 97d
Cleared Sep 09, 1992
SYSTEMATE DIRECT BILIRUBIN TEST TECHNICON RA 1000
K922856 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 86d
Cleared Sep 09, 1992
SYSTAMATE ASPARTATE AMINOTRANSFERASE TEST TECHNICO
K922857 · CIT
Em Diagnostic Systems, Inc.
Chemistry · 86d
Cleared Sep 09, 1992
SYSTEMATE CALCIUM TEST TECHNICON RA 1000
K922953 · CIL
Em Diagnostic Systems, Inc.
Chemistry · 83d
Cleared Sep 09, 1992
CLEANIC
K923020 · EJR
Hawe Neos Dental
Dental · 78d
Cleared Sep 09, 1992
MILES URINE UREA NITROGEN METHOD
K923035 · CDQ
Heraeus Kulzer, Inc.
Chemistry · 82d
Cleared Sep 09, 1992
URINE CHLORIDE
K923036 · CHJ
Heraeus Kulzer, Inc.
Chemistry · 82d
Cleared Sep 09, 1992
TOTAL BILIRUBIN CATALOG NO. 65407
K923083 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 76d
Cleared Sep 09, 1992
KING DIAGNOSTICS GAMMA GT REAGENT
K923091 · JPZ
King Diagnostics, Inc.
Chemistry · 76d
Cleared Sep 09, 1992
HCG PREGNANCY ONE STEP TEST STRIP
K923123 · JHI
Tcpi, Inc.
Chemistry · 75d
Cleared Sep 09, 1992
KING DIAGNOSTICS CHOLESTEROL REAGENT
K923128 · CHH
King Diagnostics, Inc.
Chemistry · 75d
Cleared Sep 09, 1992
NEXUS WHEELCHAIR CUSHION/FORMERLY BIOTHOTIC
K923186 · KNN
Roho, Inc.
Physical Medicine · 71d
Cleared Sep 09, 1992
SYSTEMATE CREATININE TEST
K923203 · CGX
Em Diagnostic Systems, Inc.
Chemistry · 76d
Cleared Sep 09, 1992
SYSTEMATE TOTAL PROTEIN TEST, TECHNICON RA 1000
K923267 · CEK
Em Diagnostic Systems, Inc.
Chemistry · 69d
Cleared Sep 09, 1992
VENEER CEMENT
K923328 · EMA
Dentsply Intl.
Dental · 64d
Cleared Sep 09, 1992
LUEKOFLEX SURGICAL TAPE
K923404 · KGX
Beiersdorf, Inc.
General & Plastic Surgery · 61d
Cleared Sep 09, 1992
AMYLASE TEST
K923677 · JFJ
Em Diagnostic Systems, Inc.
Chemistry · 49d
Cleared Sep 09, 1992
ENDOPATH TISSUE RETAINING COMPONENT
K923679 · KCJ
Ethicon Endo-Surgery, Inc.
Ear, Nose, Throat · 49d
Cleared Sep 09, 1992
SURGISTAR BLADES
K923689 · GDX
Surgistar, Inc.
General & Plastic Surgery · 47d