10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ASCEND SPINAL FIXATION SYSTEM WITH THE SHADOW SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SYNCHRON SYSTEMS AMMONIA REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GORE® TAG® THORACIC ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·March 24, 2016
OT PING ENHANCED METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 22, 2015
CS300
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·August 21, 2014
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·May 3, 2011
C8701, S ALEXIS LAP SYS W/ KII FIOS 5/BX
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code GCJ·November 14, 2016
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code BWC·September 4, 2019
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