8 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ISP Safety Huber Needle Infusion Set
FDA 510(k)
FDA Class 2
·General Hospital
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776414207·Breisky Vaginal Spec 180mm x 40mm
LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SYNAPSE OBLIQUUS MIP/MPR/FUSION
FDA 510(k)
FDA Class 2
·Radiology
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 5, 2013
ACCU-CHEK FLEXLINK
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code FRN·June 22, 2011
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·October 14, 2014
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018