18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FUTURABOND UNIVERSAL
FDA 510(k)
FDA Class 2
·Dental
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450397152·
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
FDA 510(k)
FDA Class 1
·General Hospital
ACCUSOM
FDA 510(k)
FDA Class 2
·Anesthesiology
LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·August 8, 2016
GALAXY G3 XSFT 3.5MM X 7.5CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·November 2, 2022
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 24, 2013
LIFEPAK CR(R) PLUS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·September 30, 2014
OPTIVANTAGE WITH PEDESTAL
FDA Adverse Event
Injury
·LIEBEL-FLARSHEIM CO·Product code IZQ·June 14, 2011
GALAXY G3 MINI 1MM X 3CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·November 2, 2022
GALAXY G3 MINI 1MM X 2CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·November 2, 2022
GALAXY G3 MINI 2MM X 6CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·November 2, 2022
GALAXY G3 XSFT 3MM X 6CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·November 2, 2022
GALAXY G3 MINI 1.5MM X 3CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·November 2, 2022
SLEEK OTW PTA CATHETER
FDA Adverse Event
Injury
·CLEARSTREAM TECHNOLOGIES LTD.·Product code DQY·December 13, 2023
GALAXY G3 MINI 1.5MM X 3CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·November 2, 2022
GALAXY G3 5MM X 15CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·November 2, 2022
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012