11 results
·
76ms
·
Sources: EU EUDAMED, US FDA
COMPLETE MOISTURE PLUS
FDA Adverse Event
Malfunction
·ADVANCED MEDICAL OPTICS, INC·Product code LPN·January 24, 2008
THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code LPB·December 11, 2024
AU5421-02 CLINICAL CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER MISHIMA K.K.·Product code JJE·December 1, 2011
THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code LPB·July 24, 2024
SAPPHIRE M.T INFUSION PUMP
FDA Adverse Event
Malfunction
·Q CORE MEDICAL LTD.·Product code FRN·November 24, 2016
THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·October 10, 2016
TECNIS TORIC
FDA Adverse Event
Injury
·AMO PUERTO RICO MFG. INC.·Product code HQL·January 10, 2025
HEALON DUET
FDA Adverse Event
Malfunction
·AMO UPPSALA AB·Product code LZP·February 19, 2025
4Z1c matrix array transducer which is used with ACUSON SC2000 ultrasound system. Siemens Medical Solutions USA, Inc. Business Unit Ultrasound 1230 Shorebird Way Mountain View, CA 94043 Intended use: 4Z1 transducer is a special purpose ultrasound transducer designed to help clinicians perform adult echocardiography and pre-operative and intra-operative surgical assessments. Secondary applications include: pediatric, echocardiography, primarily benefiting older and larger pediatric populations, general abdominal and Pinta-operative pediatric abdominal imaging and peripheral vessel imaging.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code IYN·September 29, 2010
ACUSON SC 2000 ultrasound system. Siemens Medical Solutions USA, Inc. Business Unit Ultrasound 1230 Shorebird Way Mountain View, CA 94043 Intended use: SC2000 ultrasound system is intended for the following applications: Cardiac, neo-Natal and fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, Musculo-skeletal Conventional, and anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medial data obtained by a physician for clinical diagnosis purposes.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code IYN·September 29, 2010
SUNGO Europe B.V.
Authorized representative
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