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
172465–172488 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 18, 1977
ALKALINE PHOSPHATASE TEST
K771695 · CJE
Sclavo, Inc.
Chemistry · 42d
Cleared Oct 18, 1977
DERTRAN-COATED CHARCOAL TABLETS
K771704
Reflex Industries, Inc.
Chemistry · 42d
Cleared Oct 18, 1977
TEK-CHEK-2
K771713 · JJW
Miles Laboratories, Inc.
Chemistry · 36d
Cleared Oct 18, 1977
BARBITAL BUFFER
K771721
Sigma Chemical Co.
Chemistry · 35d
Cleared Oct 18, 1977
GLUCOSE REAGENT FOR GLUC. ANALYZER
K771754 · CGA
Harleco
Chemistry · 32d
Cleared Oct 18, 1977
FOLLICLE-STIMULATING HORMONE
K771756 · CGJ
Nichols Institute Diagnostics
Chemistry · 32d
Cleared Oct 18, 1977
RUBA-NOST TEST KITS
K771796 · GOL
Behring Diagnostics, Inc.
Microbiology · 25d
Cleared Oct 18, 1977
LIPPOPROTEIN ELECTROPHORESIS REAGENT SET
K771812 · DFC
Gelman Instrument Co.
Immunology · 21d
Cleared Oct 18, 1977
CHOLESTEROL
K771833 · CGO
Gamma Enterprises, Inc.
Chemistry · 27d
Cleared Oct 18, 1977
UROFLOW-CYSTOMETER SYSTEM
K771850 · FAP
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 19d
Cleared Oct 18, 1977
FOLHY CATHETER
K771860 · EZL
Polysil, Inc.
Gastroenterology & Urology · 18d
Cleared Oct 18, 1977
AUTOMATED SLIDE SPINNER
K771898 · GKJ
Dynatech Cryomedical Co.
Hematology · 12d
Cleared Oct 18, 1977
VAPOR 19
K771899 · CAD
Draeger Medical, Inc.
Anesthesiology · 12d
Cleared Oct 14, 1977
125 I DIGOXIN RIA KIT
K771525 · DPB
Diagnostic Products Corp.
Toxicology · 67d
Cleared Oct 14, 1977
CURITY PEAKOMETER
K771655 · FFG
Kendall Research Center
Gastroenterology & Urology · 46d
Cleared Oct 14, 1977
CLINICARD CREATININE CHEMISTRY
K771773 · CGX
Harleco
Chemistry · 25d
Cleared Oct 14, 1977
PTH RIA
K771783 · CEW
Nichols Institute Diagnostics
Immunology · 21d
Cleared Oct 13, 1977
ID BRACLETS, ADULT & INFANT
K771158 · LDR
Divers-A-Med
General Hospital · 108d
Cleared Oct 13, 1977
IV CATHETER HUB
K771381 · FOZ
Jelco Laboratories
General Hospital · 79d
Cleared Oct 13, 1977
EMIT THYROXINE CONTROL
K771657 · JJX
Syva Co.
Chemistry · 45d
Cleared Oct 13, 1977
BLOOD GAS TRAY #4024
K771667 · FMI
Concord Laboratories, Inc.
Hematology · 43d
Cleared Oct 13, 1977
CATHETER DRESSING CHANCE SET
K771712 · FRL
Shield Laboratories, Inc.
General Hospital · 31d
Cleared Oct 13, 1977
EXAM GLOVES
K771757 · FMC
Jamar Health Products
General Hospital · 27d
Cleared Oct 13, 1977
ELASTOMULL GAUZE BANDAGE
K771758 · FQM
Beiersdorf, Inc.
General Hospital · 24d