16 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CADD CASSETTE RESERVOIR
FDA Adverse Event
Malfunction
·ST PAUL·Product code FPA·May 18, 2021
DIDECO MICRO 40 PH.I.S.I.O (PHOSPHORYLCHOLINE INSERT SURFACE IN OXGENATION) NEWBORN/INFANT ARTERIAL FILTER
FDA 510(k)
FDA Class 2
·Cardiovascular
ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0
FDA 510(k)
FDA Class 2
·Orthopedic
CADD
FDA Adverse Event
Malfunction
·SMITHS MEDICAL MD, INC.·Product code FPA·April 30, 2021
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 17, 2026
CADD LEGACY PLUS PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·June 17, 2021
ROUND FILTER POLYPROVPYLENE
FDA Adverse Event
Malfunction
·SPS MEDICAL SUPPLY CORP·Product code FRG·June 25, 2013
CADD LEGACY PLUS PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·June 17, 2021
CADD CASSETTE RESERVOIR
FDA Adverse Event
Malfunction
·ST PAUL·Product code FPA·May 18, 2021
CADD CASSETTE RESERVOIR
FDA Adverse Event
Malfunction
·ST PAUL·Product code FPA·May 18, 2021
CADD CASSETTE RESERVOIR
FDA Adverse Event
Malfunction
·ST PAUL·Product code FPA·May 18, 2021
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·May 3, 2013
EPIC?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIO·September 16, 2014
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code DRY·May 2, 2011
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