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
167449–167472 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 23, 1980
TRYPTIC SOY SXT AGAR W/SHEEP BLOOD
K792720 · JSJ
Gibco Laboratories Life Technologies,...
Microbiology · 23d
Cleared Jan 23, 1980
FIAX TEST KIT FOR GENTAMICIN QUAN.
K800032 · LCQ
Intl. Diagnostic Technology
Toxicology · 16d
Cleared Jan 23, 1980
QUANTIMUNE CORTISOL RIA CORTISOL RADIO-
K800045 · CGR
Bio-Rad
Chemistry · 15d
Cleared Jan 23, 1980
DELTA TEST AMYLASE UV
K800049 · JFJ
Bd Becton Dickinson Vacutainer...
Chemistry · 14d
Cleared Jan 23, 1980
KODAK EKTACHEM FOUR CHEMISTRY ANALYZER
K800053 · JJE
Eastman Kodak Company
Chemistry · 14d
Cleared Jan 23, 1980
PROVIT
K800060 · EMA
Parker Laboratories, Inc.
Dental · 13d
Cleared Jan 23, 1980
FLUOROMATIC PHENOLBARBITAL FIA
K800090 · DKP
Bio-Rad
Toxicology · 9d
Cleared Jan 21, 1980
CENTRIA FSH RIA
K792233 · CGJ
Union Carbide Corp.
Chemistry · 77d
Cleared Jan 21, 1980
LIVERPOOL KNEE PROSTHESIS
K792325 · HRY
Downs Surgical , Ltd.
Orthopedic · 63d
Cleared Jan 21, 1980
MOPSO BUFFER
K792574 · JCC
Electrophoresis Corp. of America
Pathology · 39d
Cleared Jan 21, 1980
SMV 120 SONIC MAMMOGRAPHIC VIEWER
K792585 · IYO
Johnson & Johnson Professionals, Inc.
Radiology · 35d
Cleared Jan 21, 1980
CRYPTOCOCCUS NEOFORMANS ANTISERUM, LATEX
K792693 · GMD
Meridian Diagnostics, Inc.
Microbiology · 25d
Cleared Jan 21, 1980
PARA-PAK FORMALIN
K792705 · IGG
Meridian Diagnostics, Inc.
Pathology · 25d
Cleared Jan 21, 1980
PARA-PAK SAF
K792707 · IGG
Meridian Diagnostics, Inc.
Pathology · 25d
Cleared Jan 21, 1980
BLOOD FLUID FILTERS
K792723 · JKA
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 21d
Cleared Jan 21, 1980
WORK SIMULATOR
K800007 · BXB
Baltimore Therapeutic Equipment Co.
Physical Medicine · 18d
Cleared Jan 21, 1980
DUPONT ACA ION SELECTIVE ELECTRODE
K800016 · CEM
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 14d
Cleared Jan 21, 1980
COLOR CODED PUTTY SOFT, REGULAR & FIRM
K800017 · ION
Fred Sammons, Inc.
Physical Medicine · 19d
Cleared Jan 21, 1980
BK-5203 FACILITATION VIBRATOR ELECTRIC
K800018 · IRO
Fred Sammons, Inc.
Physical Medicine · 19d
Cleared Jan 21, 1980
BK-1544 BE OK SCOOP DISK
K800019 · ILC
Fred Sammons, Inc.
Physical Medicine · 19d
Cleared Jan 21, 1980
WORTHINGTON FLOZYME* CPK (340NM)
K800028 · JHS
Worthington Diagnostic Systems
Chemistry · 14d
Cleared Jan 21, 1980
PENTEX LIPOPROTEIN CHOLESTEROL SOLU.
K800035 · JJX
Miles Laboratories, Inc.
Chemistry · 14d
Cleared Jan 21, 1980
TOTAL ESTRIOL RIA KIT
K800036 · CGI
Amersham Corp.
Chemistry · 14d
Cleared Jan 21, 1980
ALT REAGENT
K800038 · CKA
Gilford Diagnostics
Chemistry · 14d