13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SELF SEAL STERILIZATION POUCH
FDA 510(k)
FDA Class 2
·General Hospital
Safco One Tray Impression Trays
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310230253·Safco One Tray impression trays, #3 medium uppe...
PERFORMATRAK
FDA UDI
Respironics, Inc.·00606959000773·PerformaTrak Mask with Standard Elbow, Small, R...
MODIFICATION TO FLOUROLAB PLUS
FDA 510(k)
FDA Class 2
·Neurology
L.A.M. IPM WOUND GEL
FDA 510(k)
FDA Unclassified
·Unknown
DAVINCI XI
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·May 30, 2023
TRILOGY 200
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·March 21, 2013
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·February 24, 2011
FLO-GARD 6301 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·April 3, 2008
BIO-MEDICUS NG 27 FR VENOUS CANNULA
FDA Adverse Event
Injury
·PERFUSION SYSTEMS·Product code DWF·November 10, 2023
BD ALARIS PUMP MODULE SMARTSITE INFUSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS S.A. DE C.V.·Product code FPA·October 12, 2023
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
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018