9 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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MANI NEEDLE & SUTURE PACK (NYLON)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496053637·MICROMASSAGE ARMBANDS CCL1, SIZE XL, FUCSIA, GR...
ACTICHROME HEPARIN (ANTI-FIIA)
FDA 510(k)
FDA Class 2
·Hematology
TYTAN ELECTRONIC STETHOSCOPES (MODEL #600)
FDA 510(k)
FDA Class 2
·Cardiovascular
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 11, 2013
POWERFLEX P3 PTA DILATATION CATHETER
FDA Adverse Event
Malfunction
·CORDIS EUROPA, N.V.·Product code LIT·May 27, 2008
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 13, 2011
Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016
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