9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIOMET VISION FOOTRING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO 30 EXTENSION SET
FDA 510(k)
FDA Class 2
·General Hospital
RING ANNULOPLSTY TRICUSP CONTOUR 3D 26MM
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·July 10, 2019
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 22, 2013
PFC SIGMA/OV/DOME PAT 3PEG,35
FDA Adverse Event
Injury
·DEPUY (IRELAND)·Product code JWH·April 13, 2011
ACCOLADE (127 DEG) SIZE 5.5
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code MEH·July 3, 2008
STERRAD 100NX STERILIZER 1-DR
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·January 6, 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