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

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176,076 results
165337–165360 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 29, 1981
INPERSOL CAPD BAG PORT CLAMP
K803300 · KDJ
Abbott Laboratories
Gastroenterology & Urology · 30d
Cleared Jan 29, 1981
SIEMENS-ELEMA MYOCARDIAL LEAD
K810036 · DXY
Siemens Elema AB
Cardiovascular · 20d
Cleared Jan 29, 1981
WATER RESISTANT FOOTSWITCH W/CABLE
K810101 · GEI
Aspen Laboratories, Inc.
General & Plastic Surgery · 13d
Cleared Jan 29, 1981
INFANT ECG ELECTRODE #60-1029
K810102 · DRX
Aspen Laboratories, Inc.
Cardiovascular · 13d
Cleared Jan 29, 1981
ADULT ECG ELECTRODE #60-0724
K810103 · DRX
Aspen Laboratories, Inc.
Cardiovascular · 13d
Cleared Jan 29, 1981
ECG ARRHYTHMIA STIMULATOR
K810104 · DPS
Belmont Instrument Corp.
Cardiovascular · 13d
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