17 results
·
22ms
·
Sources: EU EUDAMED, US FDA
EXACTRAC 5.5
FDA 510(k)
FDA Class 2
·Radiology
E.COM, SYMBIA E
FDA Adverse Event
Malfunction
·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code IYX·March 15, 2012
BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT
FDA 510(k)
FDA Class 2
·Anesthesiology
MASTERGRAFT RESORBABLE CERAMIC GRANULES
FDA 510(k)
FDA Class 2
·Orthopedic
SYMBIA T-SERIES
FDA Adverse Event
Injury
·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·September 20, 2013
E.CAM, SYMBIA E, SYMBIA S, SYMBIA T SERIES
FDA Adverse Event
Injury
·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·May 31, 2013
E.CAM, SYMBIA E, SYMBIA S, SYMBIA T SERIES
FDA Adverse Event
Injury
·SIMENS MEDICAL SOLUTIONS, USA, INC. MI GROUP·Product code KPS·August 3, 2012
E.CAM, SYMBIA E
FDA Adverse Event
Injury
·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·July 13, 2012
E.CAM, SYMBIA E
FDA Adverse Event
Injury
·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code KPS·May 16, 2013
E.CAM
FDA Adverse Event
Injury
·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·January 7, 2014
PORTEX GENERAL ANESTHESIA CIRCUITS
FDA Adverse Event
Malfunction
·SMITHS MEDICAL INTERNATIONAL, LTD.·Product code CAI·May 18, 2022
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 23, 2013
REFURBED COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·April 29, 2011
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·July 10, 2008
E.CAM, SYMBIA E
FDA Adverse Event
Malfunction
·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code KPS·April 16, 2013
METRx II Tube, 14mm x 9cm stainless steel tubular retractor, Part No. 9569666
FDA Recall
Terminated
·Medtronic Sofamor Danek Instrument Manufacturing·Product code LXH·January 25, 2006
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