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BIS MODULE FOR ENVOY PATIENT MONITOR

FDA 510(k)
FDA Class 2 ·Neurology

PRECISION MONTAGE MRI

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 12, 2024

IMPROVED TRY-IN GEL

FDA 510(k)
FDA Class 2 ·Dental

PF 5050 PRESSURE UNIT, MODEL PF 5050

FDA 510(k)
FDA Class 2 ·Cardiovascular

BD INSULIN PEN NEEDLE

FDA Adverse Event
Injury ·BECTON DICKINSON AND CO.·Product code FMI·November 9, 2015

AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code FNL·April 22, 2013

OLYMPUS HF-RESECTION ELECTRODE

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code FAS·August 12, 2014

BILIARY BALLOON DILATATION CATHETER

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code FGE·April 28, 2011

PEN NDL 32G 4MM

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·October 15, 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