13 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STERRAD NX CHALLENGE PACK
FDA 510(k)
FDA Class 2
·General Hospital
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809867091·FOR MEN 20-30 MM HG THIGH MICRO DOT BAND OPEN T...
GENUA MENOPAUSE MONITOR TEST KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
FR MARSEILLE
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·December 22, 2010
EMAX 2 PLUS MOTOR
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBC·April 3, 2013
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·April 6, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
UNK
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·July 22, 2011
FR VILLEURBANNE
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·December 22, 2010
COMP LK SCR 3.5HEX 4.75X30 ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·October 18, 2022
COMP LK SCR 3.5HEX 4.75X15 ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·October 18, 2022
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