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
41401–41424 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 29, 2013
AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET
K130762 · JJY
Aalto Scientific, Ltd.
Chemistry · 40d
Cleared Apr 26, 2013
PANTHEON SPINAL IBFD SYSTEM
K113781 · MAX
Pantheon Spinal
Orthopedic · 491d
Cleared Apr 26, 2013
MASIMO RAS-125C ACOUSTIC RESPIRATION SENSOR
K120984 · DQA
Masimo Corporation
Anesthesiology · 389d
Cleared Apr 26, 2013
STERILE RADIOLUCENT SKULL PINS
K122225 · HBL
Brainlab AG
Neurology · 275d
Cleared Apr 26, 2013
ICRCO 3600M
K122510 · MUE
Icrco, Inc.
Radiology · 252d
Cleared Apr 26, 2013
DENTO TEMP
K122549 · EMA
Itena Clinical
Dental · 248d
Cleared Apr 26, 2013
PRG BARRIER COAT
K122908 · LBH
Shofu Dental Corporation
Dental · 217d
Cleared Apr 26, 2013
ABBOTT PHENOBARBITAL ASSAY
K123271 · DLZ
Microgenics Corp.
Chemistry · 189d
Cleared Apr 26, 2013
PERIOTYPE X-PERT
K123386 · DZE
Clinical House Europe GmbH
Dental · 175d
Cleared Apr 26, 2013
MULTI ANGLED ABUTMENT
K123755 · NHA
Osstem Implant Co., Ltd.
Dental · 140d
Cleared Apr 26, 2013
BODYTRONIC 200
K123921 · JOM
Bauerfeind AG
Cardiovascular · 127d
Cleared Apr 26, 2013
SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING
K123990 · DYB
Medtronic Vascular
Cardiovascular · 121d
Cleared Apr 26, 2013
NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM
K130201 · GWN
Ototronix, LLC
Neurology · 88d
Cleared Apr 26, 2013
AUDIT MICROCV VITAMIN D LINEARITY SET
K130764 · JJX
Aalto Scientific, Ltd.
Chemistry · 37d
Cleared Apr 26, 2013
CG+ ARROW PICC POWERED BY ARROW VPS STYLET
K130876 · LJS
Arrow International, Inc.
General Hospital · 28d
Cleared Apr 25, 2013
NVISION VLE IMAGING SYSTEM
K120800 · NQQ
Ninepoint Medical, Inc.
General & Plastic Surgery · 405d
Cleared Apr 25, 2013
RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND...
K122703 · LCM
Biophor Diagnostics, Inc.
Toxicology · 233d
Cleared Apr 25, 2013
VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH
K123028 · OTO
Caldera Medical, Inc.
Obstetrics & Gynecology · 209d
Cleared Apr 25, 2013
SERI SURGICAL SCAFFOLD
K123128 · OXF
Allergan
General & Plastic Surgery · 203d
Cleared Apr 25, 2013
DEONIZATION EXCHANGE TANKS, CARBON EXCHANGE TANKS
K123282 · FIP
Ultrapure & Industrial Services, LLC
Gastroenterology & Urology · 185d
Cleared Apr 25, 2013
AIRLIFE
K123527 · CAF
Care Fusion
Anesthesiology · 160d
Cleared Apr 25, 2013
METANEB
K124032 · NHJ
Hill-Rom Services Pte, Ltd.
Anesthesiology · 118d
Cleared Apr 25, 2013
ZAVATION CERVICAL PLATE SYSTEM
K130030 · KWQ
Zavation, LLC
Orthopedic · 111d
Cleared Apr 25, 2013
VAULT ALIF SYSTEM
K130445 · OVD
Spinal USA
Orthopedic · 63d