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
47473–47496 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 13, 2011
31P/1H HEAD COIL 3T
K102748 · MOS
Rapid Biomedical GmbH
Radiology · 232d
Cleared May 13, 2011
MAHE FIXATION PLATE AND SCREW SYSTEM
K102845 · HRS
Mahe Medical GmbH
Orthopedic · 226d
Cleared May 13, 2011
GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM...
K103025 · NEZ
Given Imaging , Ltd.
Gastroenterology & Urology · 213d
Cleared May 13, 2011
COTRONIC DIGITAL THERMOMETER
K103407 · FLL
Cotronic Manufacturing
General Hospital · 175d
Cleared May 13, 2011
ZOLL RESCUENET EPCR MODEL RESCUENET EPCR
K103473 · DXJ
ZOLL Medical Corporation
Cardiovascular · 170d
Cleared May 13, 2011
BT-350
K103545 · HGM
Bistos Co., Ltd.
Obstetrics & Gynecology · 162d
Cleared May 13, 2011
NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM
K103589 · LBI
Natus Medical Incorporated
General Hospital · 157d
Cleared May 13, 2011
CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085
K103635 · CAF
Aerogen, Ltd.
Anesthesiology · 151d
Cleared May 13, 2011
POWDERFREE NITRILE EXAMINATION GLOVES COATED WITH ALLOGEL,COLORS...
K110102 · LZA
Preventive Care, Inc.
General Hospital · 120d
Cleared May 13, 2011
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
K110146 · LZA
Tangshan Kaiyue Glove Co., Ltd.
General Hospital · 115d
Cleared May 13, 2011
ANGIODYNAMICS, INC. VENACURE 1470 LASER
K110225 · GEX
AngioDynamics, Inc.
General & Plastic Surgery · 108d
Cleared May 13, 2011
BEAUTIBOND MULTI
K110235 · KLE
Shofu Dental Corp.
Dental · 107d
Cleared May 13, 2011
BEAUTIBOND MULTI PR PLUS
K110252 · KLE
Shofu Dental Corp.
Dental · 105d
Cleared May 13, 2011
ENDOBON XENOGRAFT GRANULES
K110449 · LYC
Biomet 3i
Dental · 86d
Cleared May 13, 2011
COUGAR LS LATERAL CAGE SYSTEM
K110454 · MAX
Johnson & Johnson
Orthopedic · 86d
Cleared May 13, 2011
TERUMO SUPPORT CATHETER
K110540 · DQY
Terumo Medical Corp.
Cardiovascular · 77d
Cleared May 13, 2011
BD SINGLE USE, HYPODERMIC SYRINGE
K110771 · FMF
Becton, Dickinson and Company
General Hospital · 53d
Cleared May 13, 2011
ELECTRONIC SPHYGMOMANOMETER
K110774 · DXN
Contec Medical System Co., Ltd.
Cardiovascular · 53d
Cleared May 13, 2011
ELECTRONIC SPHYGMOMANOMETER
K110775 · DXN
Contec Medical Systems Co.,Ltd
Cardiovascular · 53d
Cleared May 13, 2011
VR MEDICAL ENTERAL ORAL SYRINGE
K110853 · FPD
Vr Medical
Gastroenterology & Urology · 46d
Cleared May 13, 2011
HEALTH CARE SYSTEM SOFTWARE
K110948 · NBW
Taidoc Technology Corporation
Chemistry · 39d
Cleared May 13, 2011
ONESTEP PEDIATRIC MFE'S
K110978 · MKJ
ZOLL Medical Corporation
Cardiovascular · 36d
Cleared May 13, 2011
SYNGO.VIA WEB VIEWER
K111079 · LLZ
Siemens AG Medical Solutions
Radiology · 25d
Cleared May 13, 2011
VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH
K111121 · FTL
Proxy Biomedical , Ltd.
General & Plastic Surgery · 22d