11 results
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19ms
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Sources: EU EUDAMED, US FDA
MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704294255·
TORNIER AEQUALIS REVERSE SHOLDER PROSTHESIS
FDA Adverse Event
Malfunction
·TORNIER INC.·Product code HSD·June 18, 2009
HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DORNIER LITHOTRIPTER S(DOLI S) & DORNIER LITHOTRIPTER S-XP (DOLI S-XP)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OPTETRAK
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·January 17, 2019
INFINION? CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·January 28, 2026
HOLDING SLEEVE-STANDARD FOR MATRIX
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code LXH·April 22, 2013
ILLUMENA, EUROPEAN RACK
FDA Adverse Event
Malfunction
·LIEBEL FLARSHEIM·Product code DXT·August 12, 2014
DURASUL COCR HEAD 44/-8 'XS' 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LPH·April 19, 2011
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014