11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
EZ-HCG URINE(PREGNANCY TEST)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PMH 1000 HEATED HUMIDIFIER
FDA 510(k)
FDA Class 2
·Anesthesiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 18, 2025
STRATUS CS
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code DAP·November 11, 2015
STRATUS CS
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code DAP·November 9, 2015
PFNA-II BLADE L100 TAN
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HSB·April 17, 2013
AED10
FDA Adverse Event
Malfunction
·WELCH ALLYN PROTOCOL, INC.·Product code MKJ·April 12, 2011
HIP IMPLANT
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS MAHWAH·Product code JDI·June 19, 2008
DIMENSION VISTA®
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code MMI·August 28, 2018
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