15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
OsteoMed
FDA UDI
OSTEOMED LLC·00845694091343·2.4mm x 14mm Fully Threaded Screw
MILLENNIUM
FDA UDI
Avalign Technologies, Inc.·00190776315047·Alm Retractor
PRIME ECG SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE
FDA 510(k)
FDA Class 2
·General Hospital
INNOVA 4100
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS·Product code MQB·April 4, 2011
INNOVA 4100
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS·Product code MQB·May 6, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
ANIMAS CORPORATION·Product code LZG·April 11, 2013
TRUFILL DCS ORBIT MINI COMPLEX FILL
FDA Adverse Event
Malfunction
·CORDIS NEUROVASCULAR, INC.·Product code HCG·April 13, 2011
VITROS IMMUNODIAGNOSTICS PRODUCTS TROPONIN I ES REAGENT PACK
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·May 20, 2008
INFUSE BONE GRAFT/LT-CAGE
FDA Adverse Event
Injury
·MEDTRONIC·Product code NEK·November 12, 2013
LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X40 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL (MDR)·Product code HSB·May 11, 2015
LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL (MDR)·Product code HSB·May 11, 2015
LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X40 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL (MDR)·Product code HSB·May 11, 2015
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