9 results
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20ms
·
Sources: EU EUDAMED, US FDA
GOAT ANTI-HUMAN IGG GAMMA CHAIN SPECIFIC
FDA 510(k)
FDA Class 2
·Immunology
ACUMED
FDA UDI
Acumed LLC·10806378094996·Hex Driver, 3.5 mm
ZENO AI ECO DISC
FDA 510(k)
FDA Class 2
·Dental
TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
KNIFE
FDA Adverse Event
Malfunction
·ALCON PRECISION DEVICE·Product code HNN·March 24, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·October 23, 2012
MEDISENSE OPTIUM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·September 6, 2007
GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022
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