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
131737–131760 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 28, 1989
MODELS 432-03 & 433-03 IMPLANTABLE PACING LEADS
K890411 · DTB
Intermedics, Inc.
Cardiovascular · 63d
Cleared Mar 28, 1989
MODELS 430-07 & 431-07 IMPLANTABLE PACING LEADS
K890412 · DTB
Intermedics, Inc.
Cardiovascular · 63d
Cleared Mar 28, 1989
VENTREX COATED TUBE HCG
K890549 · JHI
Ventrex Laboratories, Inc.
Chemistry · 53d
Cleared Mar 28, 1989
COTUBE(TM) TSH IRMA
K890802 · JLW
Bio-Rad
Chemistry · 40d
Cleared Mar 28, 1989
CENTURION CIRCLAMP
K890897 · HFX
Tri-State Hospital Supply Corp.
Obstetrics & Gynecology · 34d
Cleared Mar 28, 1989
KODAK EKTACHEM 500/750 SERIES ANALYZER, SOFT V1.0
K890927 · JJE
Eastman Kodak Company
Chemistry · 32d
Cleared Mar 28, 1989
KODAK EKTACHEM 500 ANALYZER
K890928 · JJE
Eastman Kodak Company
Chemistry · 32d
Cleared Mar 28, 1989
KODAK EKTACHEM 750 SERIES ANALYZER
K890929 · JJE
Eastman Kodak Company
Chemistry · 32d
Cleared Mar 28, 1989
ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC)
K890997 · KEA
Atlantic Wholesale, Inc.
Chemistry · 29d
Cleared Mar 28, 1989
MAGNESIUM REAGENT
K891355 · JGJ
Medical Analysis Systems, Inc.
Chemistry · 18d
Cleared Mar 28, 1989
1570 - FETAL BLOOD SAMPLING KIT
K891388 · HGW
Transidyne General Corp.
Obstetrics & Gynecology · 14d
Cleared Mar 27, 1989
CYTOMEGALOVIRUS IGG EIA KIT
K880433 · LFZ
De Ferris Laboratories, Inc.
Microbiology · 420d
Cleared Mar 27, 1989
UBI MAGIWEL CMV IGG QUANTITATIVE
K883399 · LFZ
United Biotech, Inc.
Microbiology · 228d
Cleared Mar 27, 1989
FRANKLIN COLLECTOR(R)
K884612 · FQZ
Franklin Diagnostics, Inc.
General Hospital · 143d
Cleared Mar 27, 1989
ANAEROBIC MIC PANEL
K884831 · JWY
Microtech Medical Systems, Inc.
Microbiology · 129d
Cleared Mar 27, 1989
PERITONEAL CATHETERS WITH AN ADDED FUNCTION
K890288 · FJS
Quinton, Inc.
Gastroenterology & Urology · 67d
Cleared Mar 27, 1989
ABBOTT TESTPACK(TM) D-DIMER
K890422 · GHH
Abbott Laboratories
Hematology · 60d
Cleared Mar 27, 1989
N LATEX IGE KIT (IMMUNOGLOBULIN E REAGENTS)
K890530 · DGC
Behring Diagnostics, Inc.
Immunology · 53d
Cleared Mar 27, 1989
VISUWELL GROUP A STREPTOCOCCUS DETECTION KIT
K890840 · GTZ
Adi Diagnostics, Inc.
Microbiology · 34d
Cleared Mar 24, 1989
ACCESSORY TO EYEDROP GUIDE
K884974 · JYJ
Suredrop, Inc.
Ear, Nose, Throat · 114d
Cleared Mar 24, 1989
GAMMA-GLUTAMYLTRANSFERASE
K890312 · JQB
American Monitor Corp.
Chemistry · 60d
Cleared Mar 24, 1989
LATEX EXAMINATION GLOVE
K890462 · LYY
C.R. Trading, Inc.
General Hospital · 53d
Cleared Mar 24, 1989
INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEM
K890509 · HQF
Biophysic Medical, Inc.
Ophthalmic · 51d
Cleared Mar 24, 1989
ABBOTT OVULATION PREDICTOR TEST
K890510 · CEP
Abbott Laboratories
Chemistry · 51d