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
35233–35256 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 23, 2015
PULSE OXIMETER CMS50EW
K141362 · DQA
Contec Medical Systems Co.,Ltd
Anesthesiology · 335d
Cleared Apr 23, 2015
STARBAND, STARLIGHT
K142141 · OAN
Orthomerica Products, Inc.
Neurology · 261d
Cleared Apr 23, 2015
SOLSTICE OCT System
K142253 · KWP
Life Spine, Inc.
Orthopedic · 252d
Cleared CT Apr 23, 2015
HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS)
K142282 · ETD
Preceptis Medical
Ear, Nose, Throat · 251d
Cleared Apr 23, 2015
ConMed Mixing and Delivery Kit
K142535 · FMF
Conmed Corporation
General Hospital · 226d
Cleared Apr 23, 2015
IntraNovo 25 Microcatheter
K142817 · DQO
Texasmedical Technologies, Inc.
Cardiovascular · 206d
Cleared Apr 23, 2015
iBreastExam
K142926 · NKA
Ue Lifesciences, Inc.
Obstetrics & Gynecology · 197d
Cleared Apr 23, 2015
Galt Tork, 0.010 to 0.020 inches (yellow), Galt Tork, 0.025 to 0.040 inches...
K143252 · DQX
Needle Tech Products, Inc.
Cardiovascular · 161d
Cleared Apr 23, 2015
BHV VIVID (etafilcon A) Soft (Hydropholic) Contact Lens
K143280 · LPL
Brien Holden Vision Pty , Ltd.
Ophthalmic · 160d
Cleared Apr 23, 2015
Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments
K143320 · HBE
Stryker Corp.
Neurology · 155d
Cleared Apr 23, 2015
Noblex Long Pulse Alexandrite Laser
K143666 · GEX
Finemec Co., Ltd.
General & Plastic Surgery · 121d
Cleared Apr 23, 2015
NuVasive Reline System
K143684 · NKB
Nu Vasive, Incorporated
Orthopedic · 120d
Cleared Apr 23, 2015
Nitrile Powder Free Examination Gloves (Orange) Tested For Use With...
K150103 · LZA
Hartalega Sdn Bhd
General Hospital · 93d
Cleared Apr 23, 2015
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin...
K150110 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 93d
Cleared Apr 23, 2015
Otowave 202 Portable Tympanometer
K150163 · NAS
Amplivox, Ltd.
Ear, Nose, Throat · 87d
Cleared Apr 23, 2015
Neodent Implant System- CM Drive Implants
K150182 · DZE
Jjgc Industria E Comercio DE...
Dental · 86d
Cleared Apr 23, 2015
Zimmer Nexel Total Elbow Ulnar Cement Diverter
K150501 · JDC
Zimmer, Inc.
Orthopedic · 56d
Cleared Apr 23, 2015
Aequalis PerFORM+ Shoulder System
K150583 · KWS
Tornier, Inc.
Orthopedic · 45d
Cleared Apr 23, 2015
PRECICE Intramedullary Limb Lengthening System
K150656 · HSB
Ellipse Technologies, Incorporated
Orthopedic · 41d
Cleared Apr 23, 2015
NICO TRIOwand
K150993 · GEI
Nico Corporation
General & Plastic Surgery · 8d
Cleared Apr 22, 2015
LUNA CPAP AND AUTO-CPAP SYSTEM
K141770 · BZD
3B Medical, Inc.
Anesthesiology · 295d
Cleared Apr 22, 2015
ADVIA CENTAUR TSH
K141999 · JLW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 273d
Cleared Apr 22, 2015
RAYSCAN A-EXPERT
K142058 · MUH
Ray Co., Ltd.
Radiology · 267d
Cleared Apr 22, 2015
Jintronix
K143034 · LXJ
Jintronix, Inc.
Physical Medicine · 182d