12 results
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24ms
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Sources: EU EUDAMED, US FDA
MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BODY ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
CARRIAZO BARRAQUER SINGLE USE MICROKERATOME
FDA 510(k)
FDA Class 1
·Ophthalmic
VELA VENTILATOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code CBK·July 21, 2015
LINER AND SHELL WITH PLASTIC BARRIER 48 MM I.D. 60 MM O.D.
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·May 3, 2023
VELA VENTILATOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code CBK·February 19, 2015
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
PINNACLE MTL INS NEUT36IDX56OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·May 6, 2013
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 4, 2014
RSP SHOULDER
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code KWS·April 14, 2011
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