19 results
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38ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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INSERTEASE
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSIS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DJ ORTHOPEDICS FEMORAL ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 19, 2024
POWERED PATIENT ROTATION BED
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code IKZ·May 3, 2013
TRIMA ACCEL
FDA Adverse Event
Malfunction
·TERUMO BCT·Product code GKT·September 16, 2014
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·May 5, 2011
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
ROD Ø5.5 SOFT CURV L70 TI
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 5, 2013
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
ROD Ø5.5 SOFT CURV L70 TI
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 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