18 results · 22ms · Sources: EU EUDAMED, US FDA

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THE MOSES APPLIANCE

FDA 510(k)
FDA Class 2 ·Dental

DYONICS VISION 337 AUTOCLAVABLE CAMERA HEAD MODEL 7209048; DYONICS AUTOCLAVABLE CAMERA COUPLER MODEL 7207905

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

VISORB SWIFT

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

NV MICROCATHETER

FDA Adverse Event
Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·July 9, 2020

RESPIRATORY HUMIDIFIER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·December 18, 2009

RESPIRATORY HUMIDIFIER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·May 17, 2010

RESPIRATORY HUMIDIFIER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·December 18, 2009

RESPIRATORY HUMIDIFIER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·November 17, 2009

STRATA 2 VALVE, SMALL

FDA Adverse Event
Injury ·MEDTRONIC NEUROSURGERY·Product code JXG·May 1, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

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

3D KNEE

FDA Adverse Event
Other ·ENCORE MEDICAL, L.P.·Product code JWH·April 21, 2011

RESPIRATORY HUMIDIFIER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD.·Product code BTT·May 25, 2010

RESPIRATORY HUMIDIFIER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD.·Product code BTT·May 31, 2010

RESPIRATORY HUMIDIFIER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD.·Product code BTT·May 31, 2010

PENTAX

FDA Adverse Event
Injury ·HOYA CORP.·Product code FDT·July 24, 2015

RESPIRATORY HUMIDIFIER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·July 7, 2011

RESPIRATORY HUMIDIFIER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·June 23, 2011

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