21 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TABLE,TREATMENT,CABINET,72X27X31
FDA UDI
Hausmann Enterprises, LLC·00840314802507·
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0430200·Sagittal Bender, Double Ended Left
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0430210·Sagittal Bender, Double Ended Right
PREG-Q EARLY PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123
FDA 510(k)
FDA Class 2
·Anesthesiology
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·November 15, 2013
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code KWP·November 15, 2013
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 21, 2025
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014
HEMOPRO2
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·March 7, 2013
NAVILYST / VAXCEL
FDA Adverse Event
Malfunction
·NAVILYST MEDICAL·Product code LJT·March 15, 2011
INSIGNIA ULTRA
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code DXY·May 8, 2008
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014
BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Injury
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code FOZ·November 7, 2018
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