15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INTELLIVUE PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
Sami the Seal
FDA UDI
VEGA TECHNOLOGIES INC.·06946159501040·1093268
LEONE SPA
FDA UDI
LEONE SPA·08033707065814·EXTRAORAL ELASTICS 3/16" 8 oz
PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Z-TOUCH
FDA 510(k)
FDA Class 2
·Neurology
SYNCHRO GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORP.·Product code DQX·October 16, 2009
5.5MM TI MIN INVASIVE CURVED ROD 200MM RADIUS/125MM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code NKB·March 12, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 5, 2013
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 16, 2014
ZIMMER ZNN CALIBRATED DRILL CANNULATED
FDA Adverse Event
Malfunction
·ZIMMER INC.·Product code HTW·May 3, 2011
SYNCHRO GUIDEWIRE
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·August 2, 2010
SYNCHRO GUIDEWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·May 27, 2010
SYNCHRO GUIDEWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·April 15, 2010
SYNCHRO2-14 SUPPORT STRAIGHT 215CM
FDA Adverse Event
Malfunction
·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code DQX·December 14, 2023
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012