13 results
·
22ms
·
Sources: EU EUDAMED, US FDA
SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM -6 CM AND 8CM ANTENNA, PERSONAL DIAGNOSTICS MANAGER (PDM) ACCESSORY KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
MLX
FDA UDI
Nuvasive, Inc.·00887517268129·MLX, 8x38x28mm 8°
MLX
FDA UDI
Nuvasive, Inc.·00887517263094·MLX, 8x38x28mm 12°
MLX
FDA UDI
Nuvasive, Inc.·00887517265302·MLX, 8x38x28mm 4°
VASO PRESS DVT FOOT GARMENT #VP 520
FDA 510(k)
FDA Class 2
·Cardiovascular
GLOVCO EBONY
FDA 510(k)
FDA Class 1
·General Hospital
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 10, 2023
KYPHX® HV-R? BONE CEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code NDN·March 14, 2014
KYPHX® HV-R? BONE CEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code NDN·June 20, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 29, 2013
RIATA PASSIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·May 10, 2011
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code LXH·July 25, 2008
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