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

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RETRACTOR LITE

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

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

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

MONOPOLAR CURVED SCISSORS INSTRUMENT

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·April 29, 2013

QUICKFLEX XL LV LEAD

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·May 10, 2011

ACCU-CHEK INFORM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·July 24, 2008

MEDTRONIC MINIMED 670G

FDA Adverse Event
Injury ·MEDTRONIC·Product code CGA·December 6, 2016

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

RESPIRATORY HUMIDIFIER

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

QUADRA-H CEMENTLESS, HA COATED STEM SIZE 4 STD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·May 19, 2016

RESPIRATORY HUMIDIFIER

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

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

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