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

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Dual-Safety Pen Needle

FDA 510(k)
FDA Class 2 ·General Hospital

WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014

FDA 510(k)
FDA Class 2 ·Anesthesiology

PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115

FDA 510(k)
FDA Class 2 ·Immunology

AESCULAP SURGICAL INSTRUMENTS

FDA Adverse Event
Injury ·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·November 27, 2019

AESCULAP SURGICAL INSTRUMENTS

FDA Adverse Event
Injury ·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·November 27, 2019

VICTORY XL DR

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, CRMD·Product code LWP·January 13, 2014

DAILY ACTIVITY ASSIST DEVICES

FDA Adverse Event
PINGHU WEIFENG MATERIAL TECHNOLOGY·Product code IKX·June 26, 2013

LEAD MODEL 302

FDA Adverse Event
Malfunction ·CYBERONICS, INC.·Product code LYJ·July 22, 2011

PROGAV SYS PED.W/SA 15 A.PRECHAMBER

FDA Adverse Event
Injury ·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·April 4, 2019

HEARTMATE 3 LVAS IMPLANT KIT

FDA Adverse Event
Injury ·THORATEC CORPORATION·Product code DSQ·December 21, 2022

LIVER ACCESS AND BIOPSY SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·July 15, 2024

PROGAV 2.0 SYS PED.W/SA15 A.PRECHAMBER

FDA Adverse Event
Injury ·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·August 6, 2020

LIVER ACCESS AND BIOPSY SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·June 29, 2020

LIVER ACCESS AND BIOPSY SET

FDA Adverse Event
Injury ·COOK INC·Product code DYB·June 14, 2024

LIVER ACCESS AND BIOPSY SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·August 19, 2021

LIVER ACCESS AND BIOPSY SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·May 15, 2023

LIVER ACCESS AND BIOPSY SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·February 14, 2023

LIVER ACCESS AND BIOPSY SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·December 7, 2023

LIVER ACCESS AND BIOPSY SET

FDA Adverse Event
Injury ·COOK INC·Product code DYB·January 27, 2022

Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024