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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
40969–40992 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 20, 2013
SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT
K121101 · JIA
Astoria-Pacific, Inc.
Chemistry · 435d
Cleared Jun 20, 2013
PHYSIOLOGICAL DATA PROCESSOR
K122763 · DRG
Zephyr Technology Corporation
Cardiovascular · 283d
Cleared Jun 20, 2013
DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A
K123106 · KPR
Samsung Electronics Co., Ltd.
Radiology · 261d
Cleared Jun 20, 2013
ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM
K130217 · MBI
OrthoPediatrics Corp.
Orthopedic · 142d
Cleared Jun 20, 2013
REFORM PEDICLE SCREW SYSTEM
K130279 · MNI
Spinal USA
Orthopedic · 135d
Cleared Jun 20, 2013
ARROW GPSCATH BALLOON DILATATION CATHETER
K130397 · LIT
Hotspur Technologies
Cardiovascular · 121d
Cleared Jun 20, 2013
FUTURABOND UNIVERSAL
K130486 · KLE
Voco GmbH
Dental · 115d
Cleared Jun 20, 2013
AIRCAST VENAFLOW ELITE SYSTEM
K130722 · JOW
Djo, LLC
Cardiovascular · 94d
Cleared Jun 20, 2013
CELLTRACKS ANALYZER II SYSTEM
K130794 · NQI
Veridex, LLC
Pathology · 90d
Cleared Jun 20, 2013
TITAN
K130795 · EWO
Interacoustics A/S
Ear, Nose, Throat · 90d
Cleared Jun 20, 2013
EXPEDIUM SPINE SYSTEM
K130877 · NKB
Medos International SARL
Orthopedic · 83d
Cleared Jun 20, 2013
XPERT MRSA/SA BLOOD CULTURE ASSAY
K130894 · NQX
Cepheid
Microbiology · 80d
Cleared Jun 20, 2013
TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED
K131543 · HEB
Procter & Gamble Co.
Obstetrics & Gynecology · 22d
Cleared Jun 19, 2013
HUMAN ALBUMIN CSF KIT
K121045 · DCF
The Binding Site Group , Ltd.
Immunology · 439d
Cleared Jun 19, 2013
JOULE 810/940/980 MULTI-PLATFORM SYSTEM
K122567 · GEX
Sciton, Inc
General & Plastic Surgery · 300d
Cleared Jun 19, 2013
VERI-Q MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM, VERI-Q PLUS MGD-1001 BLOOD...
K123007 · NBW
Mico Biomed Co., Ltd.
Chemistry · 265d
Cleared Jun 19, 2013
RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3
K130337 · JJY
Randox Laboratories Limited
Immunology · 128d
Cleared Jun 19, 2013
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR
K130564 · DXN
Health & Life Co., Ltd.
Cardiovascular · 107d
Cleared Jun 19, 2013
BASIXTOUCH
K130566 · MAV
Merit Medical Systems, Inc.
Cardiovascular · 107d
Cleared Jun 19, 2013
Z5 DIAGNOSTIC ULTRASOUND SYSTEM
K130695 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 97d
Cleared Jun 19, 2013
UNIVERSAL DISTAL RADIUS SYSTEM
K130774 · HRS
Newclip Technics
Orthopedic · 91d
Cleared Jun 19, 2013
CLL- V1 LIGHT SOURCE
K130819 · NTN
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 86d
Cleared Jun 19, 2013
VOLUSON E6/E8/E8EXPERT/E8EXPERT LIMITED EDITION/E10
K131267 · IYN
Ge Healthcare
Radiology · 47d
Cleared Jun 19, 2013
TRANSTEK BLOOD PRESSURE MONITOR
K131395 · DXN
Guangdong Transtek Medical...
Cardiovascular · 35d