12 results
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25ms
·
Sources: EU EUDAMED, US FDA
GOLOX-93
FDA 510(k)
FDA Class 2
·Anesthesiology
CADSTREAM
FDA 510(k)
FDA Class 2
·Radiology
AVIDCARE SERIES 100 TELEMANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
INFINION? CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 18, 2026
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 29, 2013
SIZE #4 4-IN-1 CUTTING BLOCK CAPTURED ASSY. TRIA.
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·April 14, 2011
PD CYCLER 110 VOLT HOMECHOICEPRO AUTOMATED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·July 18, 2008
INDUCTIGRAFT
FDA Adverse Event
Injury
·BAXTER APATECH LTD·Product code MQV·January 16, 2014
INDUCTIGRAFT
FDA Adverse Event
Injury
·BAXTER APATECH LTD·Product code MQV·June 10, 2013
INDUCTIGRAFT
FDA Adverse Event
Injury
·BAXTER APATECH LTD·Product code MQV·February 16, 2012
GORE® TRI-LOBE BALLOON CATHETER
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code DQY·February 24, 2021
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