12 results
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22ms
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Sources: EU EUDAMED, US FDA
INTELLIGENT STRAIGHT AND ARTICULAR ENDOSCOPIC LINEAR CUTTERS, VASCULAR WITH RELOADS, MODELS I30V, I45V, 160V, IR30V
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EPS320 CARDIAC STIMULATOR
FDA 510(k)
FDA Class 2
·Cardiovascular
TRILOGY ACETABULAR SYSTEM CONSTRAINED LINER, MODEL 6154 SERIES
FDA 510(k)
FDA Class 2
·Orthopedic
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·July 28, 2025
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 29, 2013
KIL OPTICAL ACCESS SYSTEM
FDA Adverse Event
Malfunction
·APPLIED MEDICAL·Product code GCJ·May 3, 2011
PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·July 23, 2008
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·October 8, 2025
CANNULA & CATHETER
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code DWF·April 22, 2025
REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL NON-LOCKING SCREW - L46
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·July 27, 2022
REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·March 9, 2021
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015