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
165097–165120 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 26, 1980
CAFFEINE REAGENT DIAZO COLORIMETRY
K802630 · CIG
American Monitor Corp.
Chemistry · 34d
Cleared Nov 26, 1980
TECA MODEL-10 ELECTROMYOGRAPH
K802637 · IKN
Teca, Inc.
Neurology · 35d
Cleared Nov 26, 1980
UCA CREAM PRODUCT REFORMULATION
K802648 · GYB
Vanaray Laboratories, Inc.
Neurology · 37d
Cleared Nov 26, 1980
MODEL T-6 EEG TELEPHONE TRANSMITTER
K802656 · GYE
Telediagnostic Systems, Inc.
Neurology · 33d
Cleared Nov 26, 1980
APTEK ULTRASOUND PROCEDURE TRAY
K802666 · HIO
Aptek , Ltd.
Obstetrics & Gynecology · 29d
Cleared Nov 26, 1980
CONTIUOUS WAVE DOPPLER ULTRASOUND
K802670 · DXK
American Edwards Laboratories
Cardiovascular · 30d
Cleared Nov 26, 1980
HP MODEL 8880A FILTER
K802686 · DRR
Hewlett-Packard Co.
Cardiovascular · 29d
Cleared Nov 26, 1980
ENTERMED ENTUNIT
K802712 · ETF
Jedmed Instrument Co.
Ear, Nose, Throat · 26d
Cleared Nov 26, 1980
COBE/STOCKERT BATTERY MODULE
K802714 · DWB
Cobe Laboratories, Inc.
Cardiovascular · 26d
Cleared Nov 26, 1980
MODEL 4700A ELECTROCARDIOGRAPH
K802718 · DPS
Hewlett-Packard Co.
Cardiovascular · 26d
Cleared Nov 26, 1980
NORMOCAP CR-102, RECORDER UNIT
K802762 · CCL
Instrumentarium-Datex
Anesthesiology · 22d
Cleared Nov 26, 1980
RESPIRGARD
K802763 · CAH
Marquest Medical Products, Inc.
General Hospital · 22d
Cleared Nov 26, 1980
RIONET HEARING AID
K802812 · KHL
Kindel & Anderson
Ear, Nose, Throat · 19d
Cleared Nov 25, 1980
ARTERIOVENOUS BLOOD TUBING SETS
K802874 · FJK
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 8d
Cleared Nov 24, 1980
IN VITRO DIAGNOSTIC STANDARDS
K802278 · DIF
Supelco, Inc.
Toxicology · 73d
Cleared Nov 24, 1980
ROBERTSON OBTURATION MONITOR INSUFFLA
K802374 · FAP
Endotek Corp.
Gastroenterology & Urology · 56d
Cleared Nov 24, 1980
SERUM T4 BY ENZYME IMMUNOASSAY
K802573 · CDX
Worthington Diagnostic Systems
Chemistry · 38d
Cleared Nov 24, 1980
MEDIUM SIZE OXYGEN HOOD #1547
K802653 · BYL
Ann Arbor Plastics, Inc.
Anesthesiology · 31d
Cleared Nov 24, 1980
ANSWER AT-HOME PREGNANCY TEST KIT
K802660 · JHJ
Armkel, LLC
Chemistry · 31d
Cleared Nov 24, 1980
CYBREX TOBRAMYCIN
K802668 · LCR
Abbott Laboratories
Toxicology · 28d
Cleared Nov 24, 1980
CARDIOACTIVE DRUGS CONTROL
K802672 · DIF
Fisher Scientific Co., LLC
Toxicology · 28d
Cleared Nov 24, 1980
HELIOBOND
K802681 · KLE
Vivadent (Usa), Inc.
Dental · 27d
Cleared Nov 24, 1980
CONTACT SEAL
K802682 · EBC
Vivadent (Usa), Inc.
Dental · 27d
Cleared Nov 24, 1980
HELIOSIT
K802683 · EBF
Vivadent (Usa), Inc.
Dental · 27d