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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