FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
40393–40416 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 19, 2013
COALIGN INNOVATIONS ACCULIF XL IBF CAGE
K131443 · MAX
Coalign Innovations, Inc.
Orthopedic · 30d
Cleared Jun 18, 2013
VIKY UP
K122820 · LKF
Endocontrol
Obstetrics & Gynecology · 277d
Cleared Jun 18, 2013
VERI-Q SELF-TESTING AND VERI-Q PLUS MGD-2001 BLOOD GLUCOSE MONITORING SYSTEMS
K123016 · NBW
Mico Biomed Co., Ltd.
Chemistry · 264d
Cleared Jun 18, 2013
TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONBIO AC500 AC800...
K123087 · NBW
Tyson Bioresearch, Inc.
Chemistry · 260d
Cleared Jun 18, 2013
VIVO 50
K123144 · NOU
Ge Healthcare, Breas Medical AB
Anesthesiology · 256d
Cleared Jun 18, 2013
IDS ISYS 1,25 DIHYDROXY VITAMIN D, IDS-ISYS, 1,25 DIHYDROXY VITAMIN D CONTROL...
K123253 · MRG
Immunodiagnostic Systems , Ltd.
Chemistry · 244d
Cleared Jun 18, 2013
TITAN REVERSE SHOULDER SYSTEM
K130050 · KWS
Ascension Orthopedic
Orthopedic · 160d
Cleared Jun 18, 2013
BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM
K130298 · JDW
Biopro, Inc.
Orthopedic · 131d
Cleared Jun 18, 2013
IU22 DIAGNOSTIC ULTRASOUND SYSTEM
K130499 · IYN
Philips Ultrasound, Inc.
Radiology · 112d
Cleared Jun 18, 2013
MULTI LEAD TRIAL CABLE
K130545 · GZB
St Jude Medical
Neurology · 109d
Cleared Jun 18, 2013
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR
K130563 · DXN
Health & Life Co., Ltd.
Cardiovascular · 106d
Cleared Jun 18, 2013
DURABLUE STERILIZATION WRAP
K130927 · FRG
Cardinal Health200, LLC
General Hospital · 76d
Cleared Jun 18, 2013
EVENFLO ADVANCED DOUBLE ELECTRIC BREAST PUMP
K131153 · HGX
Evenflo Feeding Incorporated
Obstetrics & Gynecology · 55d
Cleared Jun 18, 2013
ACTITOUCH ACT-ADAPTIVE COMPRESSION THERAPY SYSTEM
K131193 · JOW
Tactile Systems Technology, Inc.
Cardiovascular · 53d