21 results
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20ms
·
Sources: EU EUDAMED, US FDA
XBO1-824-18/19/20 BIOPSY FORCEPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040008638·Zirlux 16+ C1 89x17x18
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033354810·
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0120140·Screwdriver, Polyaxial, Standard, Cannulated, L...
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033354797·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033354773·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033354827·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033354803·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033356227·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033354780·
AB CARDIETTE DAEDALUS VIEW BASE AND AB CARDIETTTE DAEDALUS VIEW HES
FDA 510(k)
FDA Class 2
·Cardiovascular
MODEL 455GE PHASED ARRAY WRIST COIL
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·October 28, 2020
ENDOCARE, CRYOCARE, CRYOPROBE
FDA Adverse Event
Malfunction
·HEALTHTRONICS, INC.·Product code GEH·April 2, 2012
FEMOSTOP
FDA Adverse Event
Malfunction
·RADI MEDICAL SYSTEMS, INC.·Product code MGB·November 21, 2003
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 14, 2007
APEX HP M ADULST HOLLOW FIBER MEMBRANE OXYGENATOR
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·March 13, 2013
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·February 28, 2011
FEMOSTOP
FDA Adverse Event
Injury
·RADI MEDICAL SYSTEMS·Product code DXC·August 20, 2003
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