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
40993–41016 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 19, 2013
COALIGN INNOVATIONS ACCULIF XL IBF CAGE
K131443 · MAX
Coalign Innovations, Inc.
Orthopedic · 30d
Cleared CT 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
Cleared Jun 18, 2013
OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM
K131445 · HRS
Osteomed LP
Orthopedic · 29d
Cleared Jun 17, 2013
STELLAR 150
K122715 · MNT
Resmed Germany, Inc.
Anesthesiology · 285d
Cleared Jun 17, 2013
Advin Multi-Drug Screen Test Cassette, Dip Card and Cup
K122809 · DKZ
Advin Biotech
Toxicology · 277d
Cleared Jun 17, 2013
DREAM COLOR I (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, DREAM COLOR II...
K123431 · LPL
Dreamcon Co., Ltd.
Ophthalmic · 222d
Cleared Jun 17, 2013
VINYL EXAMINATION POWDER FREE GLOVES, CLEAR
K123590 · LYZ
Weilin Plastic and Rubber Products...
General Hospital · 208d
Cleared Jun 17, 2013
SOFIA STREP A FIA
K123793 · GTY
Quidel Corporation
Microbiology · 189d
Cleared Jun 17, 2013
RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM
K130309 · GXR
Biomet Microfixation
Neurology · 130d
Cleared Jun 17, 2013
AZUR PUSHABLE 18 & 35 SYSTEM
K130577 · KRD
MicroVention, Inc.
Cardiovascular · 104d
Cleared Jun 15, 2013
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE...
K130414 · LIT
Trireme Medical, Inc.
Cardiovascular · 116d
Cleared Jun 14, 2013
ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE...
K121214 · MMI
Beckman Coulter, Inc.
Chemistry · 417d