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
160633–160656 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 08, 1982
MEM VITAMINS (100X
K820509 · KIT
Dutchland Laboratories, Inc.
Chemistry · 44d
Cleared Apr 08, 1982
DISPO FIBRIN PIPET TIPS B4182-2
K820532 · GIE
American Scientific Products
Hematology · 37d
Cleared Apr 08, 1982
B4182-1
K820533 · GIE
American Scientific Products
Hematology · 37d
Cleared Apr 08, 1982
WALK-A-CYCLE
K820711 · ITJ
Walk-A-Cycle Division
Physical Medicine · 24d
Cleared Apr 08, 1982
EMIT-ST URINE COCAINE METABOLITE ASSAY
K820773 · DID
Syva Co.
Toxicology · 16d
Cleared Apr 08, 1982
ASO SURE
K820785 · GTQ
Analytical Products, Inc.
Microbiology · 16d
Cleared Apr 08, 1982
ASO SURE PLUS
K820786 · GTQ
Analytical Products, Inc.
Microbiology · 16d
Cleared Apr 08, 1982
HELENA ABNORMAL HBA2 QUIK COLUMN CONTROL
K820787 · JCM
Helena Laboratories
Hematology · 16d
Cleared Apr 08, 1982
#4005 TSA SLANT-TUBED MEDIA
K820791 · JSG
Biomedica, Inc.
Microbiology · 16d
Cleared Apr 08, 1982
#19041-150X15MM MUELLER HINTON
K820792 · JTZ
Biomedica, Inc.
Microbiology · 16d
Cleared Apr 08, 1982
#1904L MUELLER HINTON W/5% SHEEP BLOOD
K820793 · JTZ
Biomedica, Inc.
Microbiology · 16d
Cleared Apr 08, 1982
#19012 CHOCOLATE MUELLER HINTON-150X15MM
K820794 · JTZ
Biomedica, Inc.
Microbiology · 16d
Cleared Apr 08, 1982
#4006 TSB-TUBED MEDIA
K820795 · JSC
Biomedica, Inc.
Microbiology · 16d
Cleared Apr 08, 1982
#4001 TUBED MEDIA - FLUID THIOGLYCOLLATE
K820796 · JSC
Biomedica, Inc.
Microbiology · 16d
Cleared Apr 08, 1982
#50001 QUADE DIAGNOSTIC SYSTEM
K820797 · JSI
Biomedica, Inc.
Microbiology · 16d
Cleared Apr 08, 1982
#2001 HEKTOEN
K820798 · JSI
Biomedica, Inc.
Microbiology · 16d
Cleared Apr 08, 1982
#2002 MANNITOL SALT AGAR
K820799 · JSJ
Biomedica, Inc.
Microbiology · 16d
Cleared Apr 08, 1982
#2006 SALMONELLA SHIGELLA AGAR
K820800 · JSI
Biomedica, Inc.
Microbiology · 16d
Cleared Apr 08, 1982
#2007 XLD
K820801 · JSI
Biomedica, Inc.
Microbiology · 16d
Cleared Apr 08, 1982
#2009 BIGGY AGAR
K820802 · JSI
Biomedica, Inc.
Microbiology · 16d
Cleared Apr 08, 1982
#2003 MYCOBIOTIC AGAR
K820803 · JSJ
Biomedica, Inc.
Microbiology · 16d
Cleared Apr 08, 1982
#2013 CNA 5% SHEEP BLOOD
K820804 · JSJ
Biomedica, Inc.
Microbiology · 16d
Cleared Apr 08, 1982
#2005 SABOURAUD DEXTROSE AGAR/#4002 SLA
K820805 · JSJ
Biomedica, Inc.
Microbiology · 16d
Cleared Apr 08, 1982
#2004 PHENYLETHYL ALCHOL AGAR W/SHEEP BL
K820806 · JSJ
Biomedica, Inc.
Microbiology · 16d