12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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