12 results · 36ms · Sources: EU EUDAMED, 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