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
59137–59160 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 16, 2007
EZFIT DIGITAL HEATING TENS (MODEL NO.: HR-661/UC-101)
K070299 · GZJ
Ezfit Technology, Inc.
Neurology · 166d
Cleared Jul 16, 2007
BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM, MODEL NICAS 2004 SLIM
K070500 · DSB
Ni Medical
Cardiovascular · 145d
Cleared Jul 16, 2007
WELMED HYPODERMIC SYRINGE
K070936 · FMF
Welmed, Inc.
General Hospital · 104d
Cleared Jul 16, 2007
VARISOURCE IX HDR AFTERLOADER
K071467 · JAQ
Varian Medical Systems, Inc.
Radiology · 48d
Cleared Jul 16, 2007
CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER
K071494 · DTZ
Terumo Corp.
Cardiovascular · 47d
Cleared Jul 13, 2007
POINTE 360
K062118 · CFR
Pointe Scientific, Inc.,
Chemistry · 353d
Cleared Jul 13, 2007
I-CHROMA CRP TEST
K062981 · DCN
Boditech Diagnostics, Inc.
Chemistry · 287d
Cleared Jul 13, 2007
SILVAKLENZ SKIN AND WOUND CLENSER SOLUTION
K063069 · FRO
Medical Molecular Therapuetics, LLC
General & Plastic Surgery · 280d
Cleared Jul 13, 2007
PC-60, NON-INVASIVEPULSE OXIMETER
K063641 · DQA
Shenzhen Creative Industry Co., Ltd.
Anesthesiology · 218d
Cleared Jul 13, 2007
SILCRYST SILVER ANTIMICROBIAL WOUND CREAM, MODEL A-00901
K063805 · FRO
Nucryst Pharmaceuticals, Inc.
General & Plastic Surgery · 203d
Cleared Jul 13, 2007
RAPIDCOOL PATIENT TEMPERATURE MANAGEMENT SYSTEM
K070112 · DWJ
Medcool, Inc.
Cardiovascular · 183d
Cleared Jul 13, 2007
TRIPORE, MODELS HA, BP90, BP15
K070132 · MQV
Orthogem Limited
Orthopedic · 178d
Cleared Jul 13, 2007
KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT
K070183 · OCN
Kronus Market Development Associates,...
Immunology · 175d
Cleared Jul 13, 2007
MOSAIC LASER SYSTEM
K070392 · GEX
Lutronic Corporation
General & Plastic Surgery · 154d
Cleared Jul 13, 2007
ORTHOPRO STEINMAN PINS AND KIRSCHNER WIRES
K070555 · HTY
Orthopro, LLC
Orthopedic · 136d
Cleared Jul 13, 2007
ON THE GO SHARPS
K070577 · MMK
Medport, Inc.
General Hospital · 135d
Cleared Jul 13, 2007
SILVER ALGINATE II WOUND DRESSING
K070581 · FRO
Advanced Medical Solutions Limited
General & Plastic Surgery · 134d
Cleared Jul 13, 2007
CUSTOMIZED SOUND THERAPY (CST)
K070599 · KLW
Tinnitus Otosound Products, LLC
Ear, Nose, Throat · 133d
Cleared Jul 13, 2007
DEVICE MODIFICATION TO RADIUS SPINAL SYSTEM
K070631 · NKB
Stryker Spine
Orthopedic · 128d
Cleared Jul 13, 2007
AUTOVENT 4000 WITH CPAP
K070636 · BTL
Allied Healthcare Products, Inc.
Anesthesiology · 128d
Cleared Jul 13, 2007
TRILOGY ANALYZER
K070704 · CGA
Drew Scientific, Inc.
Chemistry · 122d
Cleared Jul 13, 2007
ROCHE ELECSYS PTH TEST SYSTEM
K070709 · CEW
Roche Diagnostics Corp.
Chemistry · 121d
Cleared Jul 13, 2007
RESTRAXX DATA CENTRE, MODEL R10
K070746 · BZD
Resmed, Ltd.
Anesthesiology · 116d
Cleared Jul 13, 2007
VINYL CO-POLYMER POWDER FREE EXAMINATION GLOVES, BLUE COLOR
K070852 · LYZ
Shijiazhang Hongxiang Plastic...
General Hospital · 107d