16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFICATION TO SECURACATH, MODEL: SPK01
FDA 510(k)
FDA Class 2
·General Hospital
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·January 10, 2018
MEDSTAR 150
FDA 510(k)
FDA Class 2
·Physical Medicine
PROLITE / PLASMALITE MPX PULSED LIGHT SYSTEM (PERMANENT HAIR REDUCTION)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SINAI HSP BALTIMORE MD 1
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DTZ·July 6, 2011
LAKELAND REG LAKELAND FL 1
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DWF·May 3, 2010
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 22, 2019
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·February 14, 2018
WA ADVENT TAKOMA PARK MD 1
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DTZ·November 22, 2011
IOWA METH DES MOINES IA1
FDA Adverse Event
Malfunction
·SORIN GROUP USA, INC.·Product code DTZ·March 7, 2011
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 5, 2018
COROX OTW-S 85-BP
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NKE·April 29, 2013
DUROM US ACETABULAR COMPONENT 54/48 N
FDA Adverse Event
Other
·ZIMMER GMBH·Product code KWA·April 28, 2011
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)
FDA Adverse Event
Malfunction
·COSTA RICA·Product code LTI·July 23, 2008
BD INTIMA-II Y 24GAX0.75IN PRN/PRN SLM NPVC
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·January 13, 2025
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