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
52273–52296 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 18, 2009
MARKSMANN CATHETER
K091559 · KRA
Chestnut Medical Technologies, Inc.
Cardiovascular · 113d
Cleared Sep 18, 2009
SINGLE USE SPLINTING TUBE, MODELS ST-Y0002-S, ST-Y0002-H, ST-Y0003-S AND...
K091759 · KNT
Olympus Medical Systems Corporation
Gastroenterology & Urology · 94d
Cleared Sep 18, 2009
TRYPTIK CA ANTERIOR INTERSOMATIC CERVICAL CAGE, MODELS MOS-CA 12 05-S, MOS-CA...
K091873 · ODP
Spineart
Orthopedic · 87d
Cleared Sep 18, 2009
LED CURING LIGHT, MODEL GT-1500
K091887 · EBZ
Monitex Industrial Co., Ltd.
Dental · 86d
Cleared Sep 18, 2009
BLOOD GLUCOSE MONITORING SYSTEM, MODEL FORA G90/TD-4234
K091898 · NBW
Taidoc Technology Corporation
Chemistry · 86d
Cleared Sep 18, 2009
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
K091999 · IYE
Accuray, Inc.
Radiology · 78d
Cleared Sep 18, 2009
POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES
K092000 · LYZ
Shangdong Zibo Shanchuan Medical...
General Hospital · 78d
Cleared Sep 18, 2009
OMNIPRO INCLINE
K092018 · IYE
Iba Dosimetry GmbH
Radiology · 74d
Cleared Sep 18, 2009
ABVS WORKPLACE
K092067 · LLZ
Siemens AG Medical Solutions
Radiology · 71d
Cleared Sep 18, 2009
POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES
K092100 · LYZ
Tangshan Hongxing Plastic Products...
General Hospital · 66d
Cleared Sep 18, 2009
160MLC OPTION
K092145 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 65d
Cleared Sep 18, 2009
POGO SCREW
K092189 · HWC
Fxdevices
Orthopedic · 59d
Cleared Sep 18, 2009
COPRAN ZR/ORIGIN YZ
K092496 · EIH
White Peaks Dental Systems GmbH & Co. KG
Dental · 35d
Cleared Sep 18, 2009
MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS
K092562 · HAW
FHC, Inc.
Neurology · 29d
Cleared Sep 18, 2009
VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8
K092653 · LHN
Medcom GmbH
Radiology · 21d
Cleared Sep 18, 2009
DIGITAL BLOOD PRESSURE MONITOR
K092719 · DXN
Shanghai Little Doctor Electronic...
Cardiovascular · 15d
Cleared Sep 17, 2009
COBALT MV BONE CEMENT
K091608 · LOD
Biomet Manufacturing Corp
Orthopedic · 106d
Cleared Sep 17, 2009
AMSCO EVOLUTION MEDIUM STEAM STERILIZER
K091731 · FLE
STERIS Corporation
General Hospital · 98d
Cleared Sep 17, 2009
ESOPHAGEAL STETHOSCOPE
K092716 · BZT
Truer Medical, Inc.
Anesthesiology · 14d
Cleared Sep 16, 2009
M. DIOR BRAND
K083817 · HIS
Suzhou Colour-Way Enterprise...
Obstetrics & Gynecology · 268d
Cleared Sep 16, 2009
WEDGELOC 180X STANDARD SUTURE ANCHOR WITH OPTI FIBER SUTURES,MODEL 1000-01...
K091202 · HWC
Medshape Solutions
General & Plastic Surgery · 145d
Cleared Sep 16, 2009
PRO-PICC
K091953 · LJS
Medcomp
General Hospital · 77d
Cleared Sep 16, 2009
POWDER FREE NITRILE EXAMINATION GLOVES, ORANGE (ORANGE SCENTED), WHITE...
K092200 · LZA
Gx Corporation Sdn Bhd
General Hospital · 56d
Cleared Sep 16, 2009
STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387
K092319 · ELW
Danville Materials, Inc.
Dental · 43d