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
42313–42336 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 11, 2013
VIZION + DR
K123644 · MQB
Viztek, LLC
Radiology · 46d
Cleared Jan 11, 2013
WA SERIES: WA100
K123839 · DXN
Ningbo Diaier Electronic Co., Ltd.
Cardiovascular · 29d
Cleared Jan 10, 2013
DETECT
K121206 · LQY
Forum Engineering Technologies, Ltd.
Dental · 265d
Cleared Jan 10, 2013
EVIS EXERA III VIDEO SYSTEM
K121959 · EOQ
Olympus Medical Systems Corp.
Ear, Nose, Throat · 189d
Cleared Jan 10, 2013
MANOMETER
K122077 · CAP
Intersurgical, Inc.
Anesthesiology · 178d
Cleared Jan 10, 2013
EM3 AEM MONITOR AEM CONNECTORS
K122383 · GEI
Encision, Inc.
General & Plastic Surgery · 157d
Cleared Jan 10, 2013
MEDTRONIC XOMED, INC.
K122391 · LRK
Medtronic Xomed, Inc.
Dental · 156d
Cleared Jan 10, 2013
BLOOD CULTURE HOLDER
K122687 · JKA
Greiner Bio-One North America, Inc.
Chemistry · 128d
Cleared Jan 10, 2013
SPINAL ELEMENTS CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
K122771 · OVE
Spinal Elements, Inc.
Orthopedic · 122d
Cleared Jan 10, 2013
E-BEAM ND: YAG LASER
K122922 · GEX
Eclipse Aesthetics, LLC
General & Plastic Surgery · 108d
Cleared Jan 10, 2013
AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER
K123201 · GEI
Medtronic Advanced Energy, LLC
General & Plastic Surgery · 90d
Cleared Jan 10, 2013
EC SINGLE USE, POLYPECTOMY SNARE
K123223 · FDI
Endochoice, Inc.
Gastroenterology & Urology · 87d
Cleared Jan 10, 2013
OPTETRAK LOGIC CRC TIBIAL INSERT
K123342 · JWH
Exactech, Inc.
Orthopedic · 71d
Cleared Jan 10, 2013
I.FLEX BY TCS
K123396 · EBI
Thermoplastic Comfort Systems, Inc.
Dental · 66d
Cleared Jan 10, 2013
XENX STONE MANAGEMENT DEVICE
K123438 · OCY
Xenolith Medical
Gastroenterology & Urology · 63d
Cleared Jan 10, 2013
CRYO-TOUCH IV
K123516 · GXH
Myoscience, Inc.
Neurology · 57d
Cleared Jan 10, 2013
ME
K123845 · ONF
Syneron Beauty , Ltd.
General & Plastic Surgery · 28d
Cleared Jan 10, 2013
NEW COMFORT-FIT DENTAL GUARD
K123849 · OBR
Den Tek Oral Care, Inc.
Dental · 27d
Cleared Jan 10, 2013
INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION...
K123874 · FPA
Baxter Healthcare Corp
General Hospital · 24d
Cleared Jan 10, 2013
SENOMARK ULTRA BREAST TISSUE MARKER
K123911 · NEU
C.R. Bard, Inc.
General & Plastic Surgery · 22d
Cleared Jan 09, 2013
LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE,...
K121399 · NSU
Luminex Corp.
Immunology · 245d
Cleared Jan 09, 2013
APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER
K122062 · OUY
Gen-Probe, Inc.
Microbiology · 180d
Cleared Jan 09, 2013
Q-FIX SUTURE ANCHOR, 1.8MM Q-FIX ACCESS TOOLS (DRILL GUIDE W/OBTURATOR, DRILL...
K122336 · MBI
Eleven Blade Solutions, Inc.
Orthopedic · 160d
Cleared Jan 09, 2013
MERITS MODEL P322FWD POWERED WHEELCHAIR
K122357 · ITI
Merits Health Products Co., Ltd.
Physical Medicine · 159d