12 results · 20ms · Sources: EU EUDAMED, US FDA

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GENERAL PATIENT MONITORS, MODELS: G3C/ G3D/ G3F/ G3G/ G3H

FDA 510(k)
FDA Class 2 ·Cardiovascular

Phonak

FDA UDI
Phonak AG·07612847826939·Phonak Ambra microM Loaner(palladium/black)

GE SIGNA ASSET IMAGING OPTION

FDA 510(k)
FDA Class 2 ·Radiology

SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901

FDA 510(k)
FDA Class 2 ·Neurology

WAVEWRITER ALPHA? 16

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 13, 2025

BDRV CANN SCW SS P/T DIA4.5X60MM

FDA Adverse Event
Injury ·BIOMET SPAIN, S.L.·Product code HRS·January 26, 2017

BDRV CANN SCW SS P/T DIA4.5X52MM

FDA Adverse Event
Injury ·BIOMET SPAIN, S.L.·Product code HRS·January 26, 2017

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 3, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 16, 2014

HEMOCHRON ELITE MICROCOAGULATION SYSTEM

FDA Adverse Event
Malfunction ·INTERNATIONAL TECHNIDYNE CORPORATION·Product code JPA·April 15, 2011

MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·October 26, 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