18 results · 33ms · Sources: EU EUDAMED, US FDA

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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