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
37393–37416 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 2014
CATARHEX 3
K133562 · HQC
Oertli Instrumente AG
Ophthalmic · 265d
Cleared Aug 12, 2014
TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE)
K134014 · MWI
Remote Diagnostic Technologies , Ltd.
Cardiovascular · 225d
Cleared Aug 12, 2014
POWDER FREE STERILE LATEX SURGICAL GLOVE, YELLOW COLOR (BRAND NAME: TITANFINE)
K140988 · KGO
Hebei Hongsen Plastics Technology Co,...
General Hospital · 117d
Cleared Aug 12, 2014
DA VINCI FIREFLY IMAGING SYSTEM
K141077 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 109d
Cleared Aug 12, 2014
ESG-400, FOOTSWITCH DOUBLE PEDAL, FOOTSWITCH SINGLE PEDAL, P-CORD
K141225 · GEI
Olympus Winter & Ibe GmbH
General & Plastic Surgery · 92d
Cleared Aug 12, 2014
Elecsys Estradiol III CalSet
K142021 · JIT
Roche Diagnostics
Chemistry · 18d
Cleared Aug 12, 2014
LLD EZ
K142116 · DRB
Spectranetics, Inc.
Cardiovascular · 8d
Cleared Aug 11, 2014
CUTERA PICOSECOND LASER SYSTEM
K133945 · GEX
Cutera, Inc.
General & Plastic Surgery · 231d
Cleared Aug 11, 2014
NEUROBLATE SYSTEM
K141983 · GEX
Monteris Medical Corp.
General & Plastic Surgery · 21d
Cleared Aug 08, 2014
SAVINA 300 SAVINA 300, COUNTRY VARIANTS
K121886 · CBK
Draeger Medical GmbH
Anesthesiology · 771d
Cleared Aug 08, 2014
BLUE NITRILE POWDER FREE EXAM GLOVES
K133325 · LZA
Shandong Xinshi Medical Products Co.,...
General Hospital · 283d
Cleared Aug 08, 2014
EMBRYOVIEWER SOFTWARE
K133712 · MQG
Unisense Fertilitech A/S
Obstetrics & Gynecology · 246d
Cleared Aug 08, 2014
DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS
K133751 · JIT
Diamond Diagnostics, Inc.
Chemistry · 242d
Cleared Aug 08, 2014
SENSILIGHT/ SENSILIGHT PLUS
K140381 · OHT
El Global Trade, Ltd.
General & Plastic Surgery · 175d
Cleared CT Aug 08, 2014
WALKAIDE SYSTEM
K140886 · GZI
Innovative Neurotronics, Inc.
Neurology · 123d
Cleared Aug 08, 2014
HYDROCLEANSE WOUND CARE SOLUTION
K141012 · FRO
Oculus Innovative Sciences
General & Plastic Surgery · 109d
Cleared Aug 08, 2014
LITHO
K141101 · GEX
Quanta System Spa
General & Plastic Surgery · 101d
Cleared Aug 07, 2014
KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE
K131384 · KMF
Kericure, Inc.
General & Plastic Surgery · 450d
Cleared Aug 07, 2014
TON-95LH, PAX-I3D ORTHO
K132983 · OAS
VATECH Co., Ltd.
Radiology · 318d
Cleared Aug 07, 2014
DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE
K133168 · LZA
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 294d
Cleared Aug 07, 2014
VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO...
K133538 · NWB
Olympus Corporation of the Americas
Gastroenterology & Urology · 262d
Cleared Aug 07, 2014
TITAN 11
K133695 · KPR
Gemss Medical Systems Co., Ltd.
Radiology · 247d
Cleared Aug 07, 2014
PREMVIA
K134037 · KGN
Biotime, Inc.
General & Plastic Surgery · 219d
Cleared Aug 07, 2014
LATERAL VBR SYSTEM
K140563 · MQP
Nu Vasive, Incorporated
Orthopedic · 155d