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
38953–38976 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 20, 2014
INFANT PHOTOTHERAPY BILITRON SKY 5006
K131196 · LBI
Fanem Lda
General Hospital · 300d
Cleared Feb 20, 2014
CANTATA(R) 2.9 MICROCATHETER
K131772 · KRA
Cook, Inc.
Cardiovascular · 248d
Cleared Feb 20, 2014
JMS SYRINGE
K132321 · FMF
JMS North America Corporation
General Hospital · 210d
Cleared Feb 20, 2014
PELLEFIRM
K132949 · PBX
Ellman International, Inc.
General & Plastic Surgery · 154d
Cleared Feb 20, 2014
NOVAGOLD HIGH PERFORMANCE GUIDEWIRE
K133076 · OCY
Neometrics, Inc.
Gastroenterology & Urology · 143d
Cleared Feb 20, 2014
UNIFY(R) DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
K133567 · KWQ
Globus Medical, Inc.
Orthopedic · 92d
Cleared Feb 20, 2014
INBONE TOTAL ANKLE
K133585 · HSN
Wrightmedicaltechnologyinc
Orthopedic · 91d
Cleared Feb 20, 2014
JAZZ SYSTEM
K133617 · OWI
Implanet, S.A.
Orthopedic · 87d
Cleared Feb 20, 2014
RELIEVA SCOUT SINUS DILATION SYSTEM
K140160 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 29d
Cleared Feb 19, 2014
RS-3000 ADVANCE
K132323 · OBO
Nidek Co., Ltd.
Ophthalmic · 209d
Cleared Feb 19, 2014
MEDICINAL LEECHES
K132958 · NRN
North America BioPharma
General & Plastic Surgery · 152d
Cleared Feb 19, 2014
MODIFICATION TO NAUTILUS SPINAL SYSTEM
K133564 · NKB
Life Spine, LLC
Orthopedic · 91d
Cleared Feb 19, 2014
8MM TROCAR KIT
K133845 · GCJ
Intuitive Surgical
General & Plastic Surgery · 63d
Cleared Feb 19, 2014
DC-N3/DC-N3S DIAGNOSTIC ULTRASOUND SYSTEM
K140030 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 44d
Cleared Feb 19, 2014
MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 WHITE CARTRIDGE
K140170 · GDW
Cardica, Inc.
General & Plastic Surgery · 27d
Cleared Feb 19, 2014
MEDOS HILITE INFANT OXYGENATOR
K140181 · DTZ
Medos Medizintechnik AG
Cardiovascular · 26d
Cleared Feb 19, 2014
30.0 INCH COLOR LCD MONITOR CCL650I2 (CL30650, MD302C6)
K140214 · LLZ
Jvckenwood Corporation
Radiology · 22d
Cleared Feb 18, 2014
COMPRESSIBLE LIMB SLEEVE SYSTEM
K130385 · IRP
Maxstar Industrial Co., Ltd.
Physical Medicine · 368d
Cleared Feb 18, 2014
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K130800 · LYZ
Kaixuan Plastic Co., Ltd.
General Hospital · 333d
Cleared Feb 18, 2014
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K130809 · LYZ
Jewel Plastic Co., Ltd.
General Hospital · 330d
Cleared Feb 18, 2014
POWDER FREE VINYL PATIENT EXAMINATION GLOVES
K130891 · LYZ
Friend Plastic Co., Ltd.
General Hospital · 323d
Cleared Feb 18, 2014
A SERIES AND Q SERIES PATIENT MONITORS
K131898 · MWI
Guangdong Biolight Meditech Co., Ltd.
Cardiovascular · 238d
Cleared Feb 18, 2014
SARNS SOFT-FLOW AORTIC CANNULA
K132451 · DWF
Terumo Cardiovascular Systems Corp.
Cardiovascular · 196d
Cleared Feb 18, 2014
TIDISHEILD
K132953 · PEM
Tidi Products,Llc
Dental · 151d