11 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
75L38EA Ultrasonic Transducer(FDA)
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904088754·
PROFEEL POWDER FREE NITRILE SURGICAL GLOVE, STERILE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DCM 2.0
FDA 510(k)
FDA Class 2
·Radiology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 2, 2013
TOTAL ASR ACET IMP SIZE 62
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·September 15, 2014
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG,·Product code NVZ·May 3, 2011
ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATIN
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code DQX·April 23, 2012
HT BALANCE GUIDE WIRE
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR·Product code DQX·February 4, 2020
IFUSE TORQ IMPLANT SYSTEM
FDA Adverse Event
Injury
·SI-BONE, INC.·Product code OUR·January 16, 2025
Various products which were contract sterilized.
FDA Enforcement
Class II
·Ongoing·Anewmed Corporation·November 6, 2019