16 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AVVIGO'+ Multi-Modality Guidance System
FDA 510(k)
FDA Class 2
·Cardiovascular
Dornier MedTech
FDA UDI
DORNIER MEDTECH AMERICA, INC.·00810116022380·600 micron core/1040 micron OD Luer Lock Diode ...
POSIFLUSH
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·April 20, 2026
XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
APTUS BLUE
FDA 510(k)
FDA Unclassified
·Unknown
INFINION 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 14, 2024
POSIFLUSH
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·May 1, 2026
BD POSIFLUSH
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code NGT·March 20, 2026
BD POSIFLUSH
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code NGT·March 20, 2026
LONG NAIL KIT R1.5, LEFT 10X260MM X 125
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·June 16, 2010
POSIFLUSH
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FOZ·April 6, 2026
PROGRAMMING WAND
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·November 6, 2008
NC TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·September 1, 2011
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013
1) 24 G x 0.75 in. BD Angiocath" Autoguard" shielded IV catheter (0.7 mm x 19 mm) made of FEP polymer catalog number 381700 2) 24 G x 0.56 in. BD Angiocath-N" Autoguard" shielded IV catheter (0.7 mm x 14 mm) made of FEP polymer catalog number 381720
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·May 25, 2016
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