21 results · 23ms · Sources: EU EUDAMED, US FDA

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HOFFMANN LIGHT SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K0730060·Rod Bender, 5.5 mm, 5 Position

SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

MITEK CUFFTACK

FDA 510(k)
FDA Class 2 ·Orthopedic

SYNCHRON VANCOMYCIN REAGENT

FDA Adverse Event
BECKMAN COULTER INC.·Product code LEH·June 10, 2011

LINEAR ST

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 28, 2021

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 11, 2025

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 3, 2025

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 23, 2025

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 27, 2024

880 HUMIDIFICATION SYSTEM

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

SPECTRA WAVEWRITER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 19, 2021

PROFILER BALLOON DILATATION CATHETER

FDA Adverse Event
Malfunction ·ANGIODYNAMICS·Product code DQY·April 8, 2013

ENDOPATH** XCEL* TROCAR

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·April 29, 2011

RIATA ST ACTIVE FIXATION

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008

880 HUMIDIFICATION SYSTEM

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD.·Product code BTT·February 15, 2010

RESPIRATORY HUMIDIFIER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 12, 2024

RESPIRATORY HUMIDIFIER

FDA Adverse Event
Injury ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·July 4, 2024

880 HUMIDIFICATION SYSTEM

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·April 15, 2010

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·December 6, 2023