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
158569–158592 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 08, 1982
VC III
K823011 · EPT
Teknar, Inc.
General & Plastic Surgery · 26d
Cleared Nov 08, 1982
SYVA ADVANCE THYROXINE ASSAY
K823034 · KLI
Syva Co.
Toxicology · 18d
Cleared Nov 08, 1982
AUTOCLAVE TESTING ADHESIVE TAPE
K823036 · JOJ
Industrias Tuk, S.A. DE C.V.
General Hospital · 25d
Cleared Nov 08, 1982
CHEMDI STEAM & GAS STERILIZATION INDICA
K823074 · JOJ
American Sterilizer Co.
General Hospital · 20d
Cleared Nov 08, 1982
REXTON
K823075
Argosy Intl. (Usa), Inc.
Gastroenterology & Urology · 20d
Cleared Nov 08, 1982
EXACTA & CONNECTA STOPCOCKS W/EXTENSION
K823120 · FMG
Pioneer Viggo, Inc.
General Hospital · 17d
Cleared Nov 05, 1982
HOME BLOOD GLUCOSE MONITOR
K822486 · CGA
Pharmaquest Corp.
Chemistry · 80d
Cleared Nov 05, 1982
DIGITAL DILUTER/DISPENSERS
K822688 · JQW
Hamilton Co.
Chemistry · 63d
Cleared Nov 05, 1982
GLUCOSCAN METER MODEL II
K822699 · CGA
Lifescan, Inc.
Chemistry · 59d
Cleared Nov 05, 1982
SOLID PHASE SIMUL TRAC VITAMIN B12
K822728 · CGN
Bd Becton Dickinson Vacutainer...
Chemistry · 58d
Cleared Nov 05, 1982
HEMO-DE
K822784 · KEM
Pmp Industries
Pathology · 52d
Cleared Nov 05, 1982
YERSINIA ISOLATION MEDIUM
K822855 · JSI
Granite Diagnostics, Inc.
Microbiology · 39d
Cleared Nov 05, 1982
COAT-A-COUNT FREE THYROXINE KIT/COMPONEN
K822882 · CEC
Diagnostic Products Corp.
Chemistry · 45d
Cleared Nov 05, 1982
EMIT CLINICAL PROCESSOR #CP-5000
K822932 · JQP
Syva Co.
Chemistry · 32d
Cleared Nov 05, 1982
GLUCOSE/UREA NITROGEN STANDARD
K822937 · JIX
Emd Chemicals, Inc.
Chemistry · 32d
Cleared Nov 05, 1982
PHADEBASE HUMYLASE CONTROL
K822938 · JJX
Pharmacia, Inc.
Chemistry · 32d
Cleared Nov 05, 1982
LANCER MSH GLUCOSE DIAG. KIT
K822958 · CGA
Sherwood Medical Co.
Chemistry · 31d
Cleared Nov 05, 1982
CONVERTORS DISPOSABLE DRESSING SPONGE
K822966 · NAB
American Hospital Supply Corp.
General & Plastic Surgery · 29d
Cleared Nov 05, 1982
DRESSING SPONGE
K822987 · NAB
Hermitage Hospital Products, Inc.
General & Plastic Surgery · 24d
Cleared Nov 05, 1982
COAGULASE PLASMA-CITRATED & EDTA
K822988 · JTL
American Scientific Products
Microbiology · 24d
Cleared Nov 05, 1982
BIO MAG TOTAL T4 RADIOIMMUNOASSAY KIT
K823004 · CDX
Bioclinical Group
Chemistry · 24d
Cleared Nov 05, 1982
GAMMA CLQ
K823009 · DAK
Gamma Medical Products, Inc.
Immunology · 24d
Cleared Nov 05, 1982
KM-KAL L1
K823042 · JIX
Kmn Products, Inc.
Chemistry · 21d
Cleared Nov 05, 1982
KM-KAL L2
K823043 · JIX
Kmn Products, Inc.
Chemistry · 21d