12 results
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36ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AVIATOR TRANSPORT INCUBATOR
FDA 510(k)
FDA Class 2
·General Hospital
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810057371318·Toboggan Arm & Leg Guard Pad, X-Large
PRECISION NOVI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 3, 2020
INTERGRO DBM
FDA 510(k)
FDA Class 2
·Orthopedic
BIOMET CRANIOFACIAL ACRYLIC CEMENT
FDA 510(k)
FDA Class 2
·Neurology
WAVEWRITER ALPHA PRIME 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 28, 2022
WAVEWRITER ALPHA PRIME 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 6, 2022
COULTER® LH 750 HEMATOLOGY ANALYXZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·April 26, 2013
HEARTSTART MRX - EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 9, 2014
BIPOLAR LEAD MODEL 300
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·April 22, 2011
GORE® TRI-LOBE BALLOON CATHETER
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code DQY·February 24, 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