10 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AVS PL PEEK SPACERS, MODELS 48351XXX AND 48353XXX
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO M2376A DEVICELINK SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
EHS SERIES TABLE TOP AUTOCLAVE, MODELS 2540 AND 3870
FDA 510(k)
FDA Class 2
·General Hospital
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·April 23, 2013
SYNCHRON® LX20 PRO CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·May 1, 2011
TENDRIL SDX
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·July 11, 2008
UNKNOWN HIP FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·February 3, 2021
TRI-LOCK BPS SZ 4 HI OFFSET
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWA·November 4, 2015
TRI-LOCK BPS SZ 7 STD OFFSET
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC·Product code KWA·November 4, 2015
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