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
40777–40800 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 17, 2013
ACRYLIC HERBST APPLIANCE
K113126 · LRK
Gergens Orthodontic Lab
Dental · 632d
Cleared Jul 17, 2013
25-OH VITAMIN D ELISA
K123660 · MRG
Euroimmun US
Chemistry · 231d
Cleared Jul 17, 2013
IMDX VANR FOR ABBOTT M2000
K123753 · NIJ
Intelligent Medical Devices, Inc.
Microbiology · 223d
Cleared Jul 17, 2013
GREENCROSS SURGICAL MASK
K123787 · FXX
Jingzhou Haixin Green Cross Medical...
General Hospital · 219d
Cleared Jul 17, 2013
DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTURE
K130083 · GAM
Demetech Corp.
General & Plastic Surgery · 184d
Cleared Jul 17, 2013
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
K130766 · DQX
Cook, Inc.
Cardiovascular · 119d
Cleared Jul 17, 2013
ENDOFLIP CATHETER
K130906 · FFX
Crospon, Ltd.
Gastroenterology & Urology · 107d
Cleared Jul 17, 2013
VALUTRODE NEUROSTIMLATION ELECTRODES
K130987 · GXY
Axelgaard Mfg. Co., Ltd.
Neurology · 99d
Cleared Jul 17, 2013
LIFE SPINE PLATEAU SPACER SYSTEM
K131077 · MAX
Life Spine
Orthopedic · 91d
Cleared Jul 17, 2013
COBAS C BILIRUBIN TOTAL GEN.3
K131544 · CIG
Roche Diagnostics
Chemistry · 49d
Cleared Jul 17, 2013
MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER
K131853 · MRD
Mentor Worldwide, LLC
General & Plastic Surgery · 26d
Cleared Jul 16, 2013
LPP (LOW PROFILE PORT)
K122402 · LJT
Pfm Medical, Inc.
General Hospital · 343d
Cleared Jul 16, 2013
EXPORT ADVANCE ASPIRATION CATHETER
K130536 · QEZ
Medtronic, Inc.
Cardiovascular · 137d
Cleared Jul 16, 2013
AMSCO V-PRO 1 LOW, V-PRO 1 PLUS, V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM
K131120 · MLR
STERIS Corporation
General Hospital · 85d
Cleared Jul 16, 2013
HERMES MEDICAL IMAGING SUITE V5.3
K131233 · KPS
Hermes Medical Solutions AB
Radiology · 76d
Cleared Jul 16, 2013
BD PEN NEEDLE
K131358 · FMI
Becton, Dickinson & CO
General Hospital · 67d
Cleared Jul 16, 2013
RADVISION
K131428 · MUJ
Acoustic Medsystems, Inc.
Radiology · 60d
Cleared Jul 16, 2013
VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM
K131434 · GWG
Visionsense, Ltd.
Neurology · 60d
Cleared Jul 16, 2013
UNIVERSAL OPAQUE
K131504 · EBF
Shofu Dental Corporation
Dental · 53d
Cleared Jul 15, 2013
25OH VITAMIN D TOTAL ELISA TEST
K123364 · MRG
Diasource Immunoassays, S.A.
Chemistry · 256d
Cleared Jul 15, 2013
611 ANKLE FUSION NAIL
K130051 · HSB
Tornier S.A.S.
Orthopedic · 187d
Cleared Jul 15, 2013
DENTEK EASY BRUSH WITH FLUORIDE
K130186 · EFW
Den Tek Oral Care, Inc.
Dental · 171d
Cleared Jul 15, 2013
TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION
K130253 · PER
Beckman Coulter, Inc.
Immunology · 164d
Cleared Jul 15, 2013
CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM - MULTI-USER VERSION
K130360 · DRG
Constant Care, LLC
Cardiovascular · 152d