18 results
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33ms
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Sources: EU EUDAMED, US FDA
MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INDUCTIGRAFT
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code MQV·April 14, 2020
ACTIFUSE (ABX E-Z-FIL PUTTY)
FDA Adverse Event
Injury
·BAXTER APATECH LTD·Product code MQV·December 23, 2013
ACTIFUSE (ABX E-Z-FIL PUTTY)
FDA Adverse Event
Injury
·BAXTER APATECH LTD·Product code MQV·December 23, 2013
ORS-3000LD
FDA 510(k)
FDA Class 1
·Physical Medicine
STERILE POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
FLOWCOUPLER, 3.0 MM
FDA Adverse Event
Malfunction
·SYNOVIS SURGICAL INNOVATIONS·Product code MVR·October 27, 2015
PENTA
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 29, 2013
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·March 29, 2011
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·April 21, 2008
FIRAZYR
FDA Adverse Event
Malfunction
·TAKEDA PHARMACEUTICALS USA INC.·Product code FMF·November 7, 2025
FIRAZYR
FDA Adverse Event
Malfunction
·TAKEDA PHARMACEUTICALS USA INC.·Product code FMF·November 7, 2025
VERITAS COLLAGEN MATRIX
FDA Adverse Event
Injury
·SYNOVIS SURGICAL INNOVATIONS·Product code FTM·March 11, 2013
DURA-GUARD PERICARDIUM WITH APEX PROCESSING
FDA Adverse Event
Injury
·SYNOVIS SURGICAL INNOVATIONS·Product code GXQ·February 26, 2013
FLOSEAL HEMOSTATIC MATRIX
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - VIENNA·Product code LMF·January 20, 2015
PERI-STRIPS DRY WITH VERITAS COLLAGEN MATRIX STAPLE LINE REINFORCEMENT
FDA Adverse Event
Injury
·SYNOVIS SURGICAL INNOVATIONS·Product code FTM·April 1, 2013
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
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016