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
164497–164520 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 28, 1981
MINIATURE ION SELECTIVE ELECTRODES
K802856 · JFP
Ionetics, Inc.
Chemistry · 77d
Cleared Jan 28, 1981
HYDROCOLLOID COMPATIBLE CREAM ALGINATE
K802882 · ELW
Buffalo Dental Mfg. Co., Inc.
Dental · 72d
Cleared Jan 28, 1981
NUCLI-PAP TM-(I125)-PAP RADIOIMMUNOAS-
K802886 · JFH
Nuclear Diagnostics, Inc.
Chemistry · 72d
Cleared Jan 28, 1981
SIMPLICITY INFUSION PUMP MODEL 2100A
K803078 · FRN
Critikon Company, LLC
General Hospital · 54d
Cleared Jan 28, 1981
HEAVY DRAINAGE PACK
K803116 · GEC
American Medical Disposable, Inc.
General & Plastic Surgery · 49d
Cleared Jan 28, 1981
MULTIX U. BUCKY TABLE X-RAY UNIT
K803130 · KPR
Siemens Corp.
Radiology · 47d
Cleared Jan 28, 1981
HERPES SIMPLEX VIRUS SEROLOGICAL REAGENT
K803132 · GQL
Microbiological Research Corp.
Microbiology · 47d
Cleared Jan 28, 1981
ELASTIC ADHESIVE BANDAGES
K803153 · KGX
Abco Dealers, Inc.
General & Plastic Surgery · 47d
Cleared Jan 28, 1981
X-RAY STAND & OPERATING CHAIR
K803162 · IYB
Downs Surgical , Ltd.
Radiology · 146d
Cleared Jan 28, 1981
SCANNER, COMPUTERIZED TOMOGRAPHIC
K803181 · JAK
General Electric Co.
Radiology · 43d
Cleared Jan 28, 1981
SUNSCENE TANNING STUDIO
K803189 · LEJ
Sunscene Tanning Studio
Radiology · 43d
Cleared Jan 28, 1981
MENSTRUAL ASPIRATION KITS
K803210 · HHK
Gynemetrics, Inc.
Obstetrics & Gynecology · 41d
Cleared Jan 28, 1981
CYBREX VALPROIC ACID
K803236 · LEG
Abbott Laboratories
Toxicology · 36d
Cleared Jan 28, 1981
HISTOLOGICAL EMBEDDING MEDIA
K803241 · KEO
Miles Laboratories, Inc.
Pathology · 36d
Cleared Jan 28, 1981
SEROCLUSTER EIA PLATES
K803242 · JTC
Corning Costar Corp.
Immunology · 36d
Cleared Jan 28, 1981
SEROCLUSTER FLEXIBLE VINYL U & V PL.
K803243 · JTC
Corning Costar Corp.
Immunology · 36d
Cleared Jan 28, 1981
ULTRASONIC STETHOSCOPE
K803246 · IYN
Sonicaid, Inc.
Radiology · 36d
Cleared Jan 28, 1981
AUTOMATED PULMONARY FUNCTION LABORATORY
K803255 · BZC
Cardio Pulmonary Instruments
Anesthesiology · 36d
Cleared Jan 28, 1981
ARTUS DRILL #6000
K803288 · DZI
Jedmed Instrument Co.
Dental · 29d
Cleared Jan 28, 1981
ARTUS DRILL #4000
K803289 · DZI
Jedmed Instrument Co.
Dental · 29d
Cleared Jan 28, 1981
ARTUS DRILL #3000
K803290 · DZI
Jedmed Instrument Co.
Dental · 29d
Cleared Jan 28, 1981
ARTUS DRILL #2000
K803291 · DZI
Jedmed Instrument Co.
Dental · 29d
Cleared Jan 28, 1981
GUARDIAN PEEL POUCHES
K803293 · FRG
Kimberly-Clark Corp.
General Hospital · 29d
Cleared Jan 28, 1981
ORTHODONTIC ELASTICS
K810010 · ECI
Orec Corp.
Dental · 23d