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
160513–160536 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 16, 1982
CULTURE MEDIA, MULTIPLE BIOCHEMICAL
K820841 · JSE
Blue Ridge Media Co.
Microbiology · 21d
Cleared Apr 16, 1982
CULTURE MEDIA, NON-SELECTIVE/DIFFER
K820842 · JSE
Blue Ridge Media Co.
Microbiology · 21d
Cleared Apr 16, 1982
CULTURE MEDIA SELECTIVE BROTH
K820843 · JSD
Blue Ridge Media Co.
Microbiology · 21d
Cleared Apr 16, 1982
CULTURE MEDIA, SELECTIVE & DIFFERENTIAL
K820844 · JSI
Blue Ridge Media Co.
Microbiology · 21d
Cleared Apr 16, 1982
DULTURE MEDIA, SELECTIVE & NON-DIFFER
K820845 · JSJ
Blue Ridge Media Co.
Microbiology · 21d
Cleared Apr 16, 1982
ANTIMICROBIAL SUSCEP. TEST, MUELLER
K820846 · JTZ
Blue Ridge Media Co.
Microbiology · 21d
Cleared Apr 16, 1982
ISOLATION OF PATHOGENIC NEISSERIA
K820847 · JTY
Blue Ridge Media Co.
Microbiology · 21d
Cleared Apr 16, 1982
BLUE RIDGE SHEEP BLOOD
K820848 · LHW
Blue Ridge Media Co.
Microbiology · 21d
Cleared Apr 16, 1982
BLUE RIDGE RABBIT BLOOD
K820849 · LHW
Blue Ridge Media Co.
Microbiology · 21d
Cleared Apr 16, 1982
COAXIAL DUAL FLOW CATHETER
K820859 · LBW
Terumo Medical Corp.
Gastroenterology & Urology · 18d
Cleared Apr 16, 1982
MEDIA FOR IN-VITRO DIAGNOSTIC USE
K820863 · JSJ
Isle Media and Sterile Products, Inc.
Microbiology · 18d
Cleared Apr 16, 1982
CORNING CERTAIN TM
K820873 · JJS
Corning Medical & Scientific
Chemistry · 18d
Cleared Apr 16, 1982
ENZYME-TEST TBC T4 UPTAKE
K820879 · KHQ
Icl Scientific
Chemistry · 17d
Cleared Apr 16, 1982
SERALYZER CK REAGENT STRIPS
K820880 · CGS
Miles Laboratories, Inc.
Chemistry · 17d
Cleared Apr 16, 1982
THYROXINE T4 KIT
K820886 · CDX
Pcl-Ria, Inc.
Chemistry · 17d
Cleared Apr 16, 1982
MODEL 5866-26 LEAD ADAPTER KIT
K820935 · DTD
Medtronic Vascular
Cardiovascular · 14d
Cleared Apr 16, 1982
INCONTINENCE PAD OR ADULT DIAPER
K820961 · EYQ
Dafoe & Dafoe, Inc.
Gastroenterology & Urology · 10d
Cleared Apr 16, 1982
WHEELCHAIR PAL
K820964 · KNO
Pryor Products
Physical Medicine · 10d
Cleared Apr 16, 1982
DISSCAP 140
K820965 · FKQ
Hospal Medical Corp.
Gastroenterology & Urology · 10d
Cleared Apr 16, 1982
DISSCAP 110
K820966 · FKQ
Hospal Medical Corp.
Gastroenterology & Urology · 10d
Cleared Apr 16, 1982
ENDOSCOPIC INJECTION NEEDLE
K820973 · FBK
Mill-Rose Laboratory
Gastroenterology & Urology · 10d
Cleared Apr 16, 1982
POLYSONIC ULTRASOUND LOTION
K827296 · MUI
Parker Laboratories, Inc.
Radiology · 17d
Cleared Apr 15, 1982
DISPOSABLE PLASTIC SYRINGE W/NEEDLE
K813223 · DXG
Sam Joo Industrial Co., Ltd.
Cardiovascular · 157d
Cleared Apr 15, 1982
GLASS SYRINGES, DRUG, LUER LOCK
K820384 · FMF
Procedure Products, Inc.
General Hospital · 65d