3,672 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPECTRANETICS GLIDELIGHT LASER SHEATH
FDA Adverse Event
Injury
·SPECTRANETICS·Product code MFA·September 17, 2016
AVANTI JXN-26
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JQC·January 28, 2025
ENTERYX PROCEDURE KIT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION- MARLBOROUGH·Product code LMN·March 3, 2009
SPECTRANETICS GLIDELIGHT LASER SHEATH
FDA Adverse Event
Injury
·SPECTRANETICS·Product code MFA·July 8, 2016
SPECTRANETICS LEAD LOCKING DEVICE
FDA Adverse Event
Injury
·SPECTRANETICS·Product code DRB·August 19, 2016
SPECTRANETICS LEAD LOCKING DEVICE
FDA Adverse Event
Injury
·SPECTRANETICS·Product code DRB·August 19, 2016
COBAS PRO C503
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS GMBH·Product code JXN·November 27, 2024
Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
FDA Recall
Terminated
·Biosite Inc·Product code DKZ·April 27, 2009
Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
FDA Recall
Terminated
·Biosite Inc·Product code DKZ·April 27, 2009
Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
FDA Recall
Terminated
·Biosite Inc·Product code DKZ·April 27, 2009
Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
FDA Recall
Terminated
·Biosite Inc·Product code DKZ·April 27, 2009
Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUE-187-071-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
FDA Recall
Terminated
·Biosite Inc·Product code DKZ·April 27, 2009
VisuaLine Propoxyphene; Propoxyphene test system, intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse.
FDA Recall
Terminated
·Sun Biomedical Laboratories, Inc.·Product code JXN·May 28, 2008
DrugCheck, Distributed by Express Diagnostics Int'l Inc., 1550 Industrial Drive, Blue Earth, MN 56013. Following cup Model numbers involved in the recall: 60670, 60700, 60713, 60717, 60870, 60923, 61012, 61019, 61023, 61024, 61040, 61042, 61057, 61102, 61105, 61203, 61204, 61206, 61208, 61301, 61303, 61401, 70603, 70809, 71032, 71043, 71055, 71065, 71202, 71204, 71205, 71401, 71402, 60718-3, 60720-6, 60925-A, 60927-3, 60930-A, 60980-3A, 61002-3, 61010-4, 61023-A, 61028-3A, 61039-4, 61040-A, 61055-A, 61056-3, 61057-6, 61100-3, 61102-3,61104-3,61105-5 CRL,61120-3,61202-4,61204-4,61204-A,61206-3A,61207-4,61302-3, 61303-A, 61401-A, 70660-3, 70716-3, 71045-A, 71055-6, 71102-3A, 71204-4, 71206-3A. In Vitro immunoassay screening device for the qualitative detection of multiple drugs of substances in human urine.
FDA Recall
Terminated
·Express Diagnostics Int'l., Inc.·Product code JXN·October 4, 2010
Enzyme Immunoassay, Propoxyphene
FDA classification
FDA Class 2
·Enzyme Immunoassay, Propoxyphene
JINS Inc.
FDA registration
JINS Inc.·3 products·🇯🇵 Japan
Vicks
FDA UDI
KAZ USA, INC.·00328785190007·VAPORIZER, WATERLESS, VICKS, VELVET PACKAGING
Acero Z1 Molar
FDA UDI
Park - Istre, LLC·00810120872421·
Vicks
FDA UDI
KAZ USA, INC.·00328785218008·VAPORIZER, WATERLESS, VICKS, VELVET PACKAGING
JENNINGS JAVELIN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery