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
160657–160680 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 08, 1982
#2011 STREP SELECTIVE AGAR
K820807 · JSJ
Biomedica, Inc.
Microbiology · 16d
Cleared Apr 08, 1982
#2008 SIMMONS CITRATE
K820809 · JSF
Biomedica, Inc.
Microbiology · 16d
Cleared Apr 08, 1982
#4004 TRIPLE SUGAR IRON AGAR SLANTS-TUBE
K820810 · JSE
Biomedica, Inc.
Microbiology · 16d
Cleared Apr 08, 1982
STAX FINGER SPLINT
K820826 · ILH
Conco Medical Co.
Physical Medicine · 13d
Cleared Apr 08, 1982
ESCORT
K820858 · INM
Amigo Sales, Inc.
Physical Medicine · 10d
Cleared Apr 06, 1982
KALLESTAD RAST REAGENTS
K820029 · DHB
Kallestad Laboratories, Inc.
Immunology · 91d
Cleared Apr 06, 1982
MCGAW FAT EMULSION SET
K820133 · FPA
American Mcgaw
General Hospital · 78d
Cleared Apr 06, 1982
J-CATHETER
K820628
Dna Medical, Inc.
General Hospital · 29d
Cleared Apr 06, 1982
QUANTIMUNE ESTRIOL RIA
K820728 · CGI
Bio-Rad
Chemistry · 20d
Cleared Apr 06, 1982
MR1 FOLLITROPIN RIA KIT
K820740 · CGJ
Microanalytic Research, Inc.
Chemistry · 19d
Cleared Apr 06, 1982
POLI-MAK MODEL F-4 (FINAL
K820748 · JJF
Pm America, Inc.
Chemistry · 18d
Cleared Apr 06, 1982
ENZYMUNE-TEST T4
K820750 · KLI
Icl Scientific
Chemistry · 18d
Cleared Apr 06, 1982
CLIRANS PRIMING SET
K820788 · FPA
Terumo Medical Corp.
General Hospital · 14d
Cleared Apr 01, 1982
1F BLOCKING ANTIBODY(57 CO) RADIOASSAY
K811927 · LIG
Corning Medical & Scientific
Hematology · 269d
Cleared Apr 01, 1982
AUTOMATED BLOOD PRESSURE SPHYGMOMANOMTR
K813522 · DXN
Vitar
Cardiovascular · 106d
Cleared Apr 01, 1982
DISPOSABLE PLASTIC SYRINGE & NEEDLE
K820062 · FMF
Marshall Davis, Inc.
General Hospital · 80d
Cleared Apr 01, 1982
PLASTIC CONNECTORS
K820371 · BYY
American Pharmaseal Div. Ahsc
General Hospital · 51d
Cleared Apr 01, 1982
OLLI 565
K820540 · DRT
Kone Instruments, Inc.
Cardiovascular · 30d
Cleared Apr 01, 1982
MALE EXTERNAL CATHETER
K820565 · KNX
Urocare Products, Inc.
Gastroenterology & Urology · 30d
Cleared Apr 01, 1982
HELENA HEMOGLOBIN DETECT COLUMN SYS
K820573 · GKA
Helena Laboratories
Hematology · 30d
Cleared Apr 01, 1982
ROCHE B-HCG RIA
K820613 · JHI
Hoffmann-La Roche, Inc.
Chemistry · 24d
Cleared Apr 01, 1982
ROCHE B-HCG STANDARDS
K820614 · JHI
Hoffmann-La Roche, Inc.
Chemistry · 24d
Cleared Apr 01, 1982
SYN-OPTICS #5200
K820624 · FET
Syn-Optics
Radiology · 24d
Cleared Apr 01, 1982
CORNING 480 FLAME PHOTOMETER
K820631 · JJO
Corning Medical & Scientific
Chemistry · 24d