Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
168289–168312 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 23, 1980
WIDEX HEARING AID MODEL 820
K792567 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 58d
Cleared Jan 23, 1980
HEARING AID, MODELS DRI-35/DL1-35
K792643 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 28d
Cleared Jan 23, 1980
TELESONIC V-101
K792644 · ESD
Telesonic, Inc.
Ear, Nose, Throat · 28d
Cleared Jan 23, 1980
BLASTOMYCES/ANTIGEN FOR IMMUNODIFUSION
K792683 · JWW
Meridian Diagnostics, Inc.
Microbiology · 27d
Cleared Jan 23, 1980
HISTOPLASMA CAPSULATUM, ANTIGEN
K792701 · GMJ
Meridian Diagnostics, Inc.
Microbiology · 27d
Cleared Jan 23, 1980
CANDIDA ALBICANS, ANTISERUM
K792713 · GMI
Meridian Diagnostics, Inc.
Microbiology · 27d
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