10 results
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19ms
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Sources: EU EUDAMED, US FDA
MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00533221·
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809842722·FOR MEN 30-40 MM HG KNEE HIGH OPEN TOE LARGE BR...
CODMAN BACTISEAL CATHETERS
FDA 510(k)
FDA Class 2
·Neurology
HAC-420 HEAD ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 5, 2025
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 11, 2013
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·May 22, 2008
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·April 13, 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