13 results
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24ms
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Sources: EU EUDAMED, US FDA
PURITAN-BENNETT 335 RESPIRATORY SUPPORT SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
SureStep™ Foley Tray System with Bard® Lubri-Sil® Catheter
FDA UDI
C. R. Bard, Inc.·00801741100567·SureStep™ Foley Tray System Bard® Lubri-Sil® Fo...
Bard® Urine Meter Foley Catheter Tray With Bard® Lubri-Sil® Catheter
FDA UDI
C. R. Bard, Inc.·00801741029387·Bard® Urine Meter Foley Catheter Tray With Bard...
1.7 mm Short PerCryo™ Cryoprobe
FDA UDI
Varian Medical Systems, Inc.·00810563020731·Right angle 1.7mm cryoprobe, short shaft, for u...
Welch Allyn, Inc.
FDA UDI
WELCH ALLYN, INC.·00732094185829·Single Use Ear Tips for OAE Hearing Screener an...
Welch Allyn, Inc.
FDA UDI
WELCH ALLYN, INC.·00732094185812·Single Use Ear Tips for OAE Hearing Screener an...
IVENT 302VC DUAL CONTROLLER
FDA 510(k)
FDA Class 2
·General Hospital
MSD SILO SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PROXIMATE** LINEAR CUTTER RELOAD - STANDARD
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·February 4, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·December 21, 2010
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 17, 2014
SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Product Codes: A119214M, A119216M, A119218M, A119416M, A153200, A300916A, A301216, A301216A, A303314A, A303316A, A303318A, A303414A, A303416A, A303418A, A304400A, A304714A, A304716A, A304718A, A304914, A304916, A304918, A307414A, A307416A, A319414AM, A319416A, A319416AM, A319418AM, A319514AM, A319516A, A319516AM, A333100A, A333416A, A339414AM, A339516AM, A339516AM, A344916, A800064, A800065, A800364, A800365, A800366, A900216, A900416, A901216, A902114, A902216, A902414, A902416, A902418, A902616, A902914, A902916, A902918, A903314A, A903316A, A903318A, A903416A, A904100, A904400A, A909116M, A909216M, A919416AM, A919516AM, A942206, A942208, A942210, A942212, A942214, A942216, A942218, A942616, A942618, A943214, A943216, A943218, MTA902416 Product Usage catheter
FDA Recall
Terminated
·Bard Medical Division·Product code MJC·December 13, 2018
SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Product Codes: A119214M, A119216M, A119218M, A119416M, A153200, A300916A, A301216, A301216A, A303314A, A303316A, A303318A, A303414A, A303416A, A303418A, A304400A, A304714A, A304716A, A304718A, A304914, A304916, A304918, A307414A, A307416A, A319414AM, A319416A, A319416AM, A319418AM, A319514AM, A319516A, A319516AM, A333100A, A333416A, A339414AM, A339516AM, A339516AM, A344916, A800064, A800065, A800364, A800365, A800366, A900216, A900416, A901216, A902114, A902216, A902414, A902416, A902418, A902616, A902914, A902916, A902918, A903314A, A903316A, A903318A, A903416A, A904100, A904400A, A909116M, A909216M, A919416AM, A919516AM, A942206, A942208, A942210, A942212, A942214, A942216, A942218, A942616, A942618, A943214, A943216, A943218, MTA902416 Product Usage catheter
FDA Enforcement
Class II
·Terminated·Bard Medical Division·February 13, 2019