11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PEREGRINE STRAIGHT LASER PROBE, MODEL PD6000.00
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IMAGEDESK
FDA 510(k)
FDA Class 2
·Radiology
SIMPLICITY STARPLUS SOFT INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
POD PACKING COIL
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code HCG·December 26, 2019
NX3 CLEAR DUAL CURE CEMENT
FDA Adverse Event
Injury
·KERR CORPORATION·Product code EMA·March 27, 2013
JAGWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA·Product code EZB·March 18, 2011
FLO-GARD 6301 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·April 5, 2008
DAVINCI XI
FDA Adverse Event
Death
·INTUITIVE SURGICAL, INC·Product code NAY·May 8, 2026
DAVINCI XI
FDA Adverse Event
Death
·INTUITIVE SURGICAL, INC·Product code NAY·May 8, 2026
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
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018