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
130201–130224 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 15, 1989
CAPTIA(R) RUBELLA-G
K883924 · LFX
Mercia Diagnostics , Ltd.
Microbiology · 333d
Cleared Aug 15, 1989
COULTER CLONE MO2
K884605 · GKZ
Coulter Immunology
Hematology · 285d
Cleared Aug 15, 1989
PROTEUS OX-19 IFA*
K885110 · GSZ
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 246d
Cleared Aug 15, 1989
BRUCELLA IFA*
K885112 · GSO
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 246d
Cleared Aug 15, 1989
IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROL
K885113 · GSN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 246d
Cleared Aug 15, 1989
SALMONELLA IFA*
K885114 · GHC
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 246d
Cleared Aug 15, 1989
CAPTIA(R) RUBELLA-M
K885300 · LFX
Mercia Diagnostics , Ltd.
Microbiology · 231d
Cleared Aug 15, 1989
TARGET(TM) CK-MB
K890295 · JHY
V-Tech, Inc.
Chemistry · 208d
Cleared Aug 15, 1989
PATIENT EXAMINATION GLOVE
K890594 · LYY
Tradexim Sdn Bhd
General Hospital · 190d
Cleared Aug 15, 1989
ABBOTT SPECTRUM AMYLASE REAGENT
K891241 · JFJ
Abbott Laboratories
Chemistry · 161d
Cleared Aug 15, 1989
SIL-MED WASTE FLUID DUMP BAG
K891471 · KDG
Sil-Med Corp.
General & Plastic Surgery · 153d
Cleared Aug 15, 1989
SOFT LENS FOLDING BLOCK
K891487 · HNR
Western Medical Products, Inc.
Ophthalmic · 151d
Cleared Aug 15, 1989
COBAS-FP REAGENT FOR VALPROIC ACID & CALIBRATORS
K891581 · LEG
Roche Diagnostic Systems, Inc.
Toxicology · 148d
Cleared Aug 15, 1989
PATIENT EXAM GLOVES (MFG. M.R. RUBBER INDUSTRIES)
K891815 · LYY
Mulpha Intl. Trading Corp. Bhd.
General Hospital · 145d
Cleared Aug 15, 1989
CHLORIDE STANDARDS ITEM #SR1041
K891999 · JIT
Em Diagnostic Systems, Inc.
Chemistry · 140d
Cleared Aug 15, 1989
MARDX LLYME DISEASE EIA (IGG & IGM) TEST SYSTEM
K892206 · LSR
Mardx Diagnostics, Inc.
Microbiology · 134d
Cleared Aug 15, 1989
KENDALL CURITY OXYGEN MASK
K892434 · BYG
The Kendal Co.
Anesthesiology · 127d
Cleared Aug 15, 1989
HIBERNATION KIT
K892660 · CAZ
Devon Industries, Inc.
Anesthesiology · 124d
Cleared Aug 15, 1989
IFA SENSIBAC GENTAMYCIN
K892720 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 123d
Cleared Aug 15, 1989
IFA SENSIBAC PENICILLIN
K892726 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 123d
Cleared Aug 15, 1989
CLINISTAT TOTAL BILIRUBIN REAGENT TEST
K892801 · CIG
Heraeus Kulzer, Inc.
Chemistry · 120d
Cleared Aug 15, 1989
DUBBLE BUTTERFLY PAT EXAM GLOVES/MFG: QUINGDAO FAC
K893236 · LYY
China National Chemical Construction...
General Hospital · 109d
Cleared Aug 15, 1989
PREPOWDERED VINYL EXAM GLOVES
K893334 · LYZ
Dynarex Corp.
General Hospital · 117d
Cleared Aug 15, 1989
AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT
K893469 · CEE
Amersham Corp.
Toxicology · 103d