13 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO CASPIAN SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·May 22, 2019
PENTRA 5D
FDA 510(k)
FDA Class 2
·Hematology
SELF-COUNTERSINKING BONE SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
VKMO 78000 3 QUADROX-I HMO 70000+VHK7000
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·February 25, 2015
VKMO 78000 #QUADROX-I HMO 70000+VHK7000
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·February 25, 2015
HLM TUBING SET W/SOFTLINE COATING
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DWF·April 6, 2016
SD/PD MEDIUM CURVED
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·May 6, 2013
SIG MOD TIB TRAY CEM COCR 2.5
FDA Adverse Event
Injury
·1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC·Product code JWH·September 16, 2014
HUT EXT DR FINAL ASSY-REVERSE
FDA Adverse Event
Malfunction
·LIEBEL-FLARSHEIM CO.·Product code KQS·April 5, 2011
EDWARDS ESHEATH INTRODUCER SET
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·December 6, 2021
EDWARDS TF SHEATH UNKNOWN
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·October 30, 2021
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