14 results · 29ms · Sources: EU EUDAMED, US FDA

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DIGITAL RADIOGRAPHY CXDI-40G COMPACT

FDA 510(k)
FDA Class 2 ·Radiology

Amara View

FDA UDI
Respironics, Inc.·00606959009202·Amara View Mask with Headgear, USA, Medium

SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

RECONSTITUTION KIT & VIAL CONNECTOR

FDA 510(k)
FDA Class 2 ·General Hospital

QUATTRODE

FDA Adverse Event
Injury ·ST JUDE MEDICAL - NEUROMODULATION·Product code GZF·July 24, 2014

ROD, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code MNH·May 14, 2019

ILIAC SCREW, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code MNH·October 16, 2019

MECHANICAL (MANUAL) WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code IOR·May 2, 2013

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 26, 2011

SYNCRHOMED II

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·August 1, 2008

POLARIS SCREW, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·January 8, 2020

Philips Respironics Amara View Minimal Contact Full-Face Mask

FDA Enforcement
Class I ·Ongoing·Philips Respironics, Inc.·October 12, 2022

INFANT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·March 21, 2011

POLARIS TRANSLATION SCREW, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·November 27, 2019