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
129601–129624 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 17, 1989
AMYLASE TEST (AML) ITEM NUMBER: 65404
K893751 · JFJ
Em Diagnostic Systems, Inc.
Chemistry · 90d
Cleared Aug 17, 1989
COAT-A-COUNT (TM) FSH IRMA
K893976 · CGJ
Diagnostic Products Corp.
Microbiology · 76d
Cleared Aug 17, 1989
TARGET CATHETERS AND GUIDE WIRES FOR PEDIATRIC USE
K894084 · DQY
Target Therapeutics
Cardiovascular · 70d
Cleared Aug 17, 1989
OPTIMA MPT SERIES III PACEMAKER, UNIPOLAR/BIPOLAR
K894185 · DXY
Telectronics Pacing Systems, Inc.
Cardiovascular · 62d
Cleared Aug 17, 1989
C.A.B. RING
K894268 · MAB
Medi-Sharp, Inc.
Cardiovascular · 56d
Cleared Aug 17, 1989
LATEX EXAMINATION GLOVES
K894635 · LYY
Ever-More Latex Products Sdn Bhd
General Hospital · 27d
Cleared Aug 17, 1989
STERILE LATEX EXAM GLOVES
K894676 · LYY
Superior Healthcare Group, Inc.
General Hospital · 24d
Cleared Aug 17, 1989
SYSTEM 2500 MEDICAL WATERBED
K894723 · IOQ
Dermanetics Corp.
Physical Medicine · 23d
Cleared Aug 15, 1989
IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT
K882674 · LKH
Icn Immunobiologicals
Microbiology · 413d
Cleared Aug 15, 1989
GONOSTAT
K883486 · LSL
Technology Management & Marketing, Inc.
Microbiology · 364d
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