10 results
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20ms
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Sources: EU EUDAMED, US FDA
MODIFICATION TO PROXIS SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
POWDER-FREE NITRILE EXAM GLOVE, LAVENDER/PURPLE
FDA 510(k)
FDA Class 1
·General Hospital
LONG TROCHANTERIC NAIL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
WAVEWRITER ALPHA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·July 16, 2025
LUX 1440
FDA Adverse Event
Malfunction
·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012
BIOLOX OPTION, HEAD, S, 44/-3.0, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·December 12, 2018
SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER AMC THROMBOSHIELD
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES, PR·Product code DXG·April 23, 2013
PFC SIGMA STAB INS SZ3 8MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·April 26, 2011
TENDRIL ST
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·July 11, 2008
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