15 results · 37ms · Sources: EU EUDAMED, US FDA

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VARIANT ALPHA-THALASSEMIA SHORT PROGRAM

FDA 510(k)
FDA Class 2 ·Hematology

ADS-GEL AND INSULATING-GEL

FDA 510(k)
FDA Class 2 ·Dental

BROAD SELF-COMPRESSING PLATE

FDA 510(k)
FDA Class 2 ·Orthopedic

BAERVELDT SHUNT

FDA Adverse Event
Injury ·ABBOTT MEDICAL OPTICS·Product code KYF·September 4, 2012

BAERVELDT SHUNT

FDA Adverse Event
Injury ·ABBOTT MEDICAL OPTICS·Product code KYF·September 4, 2012

BAERVELDT SHUNT

FDA Adverse Event
Injury ·ABBOTT MEDICAL OPTICS·Product code KYF·September 4, 2012

BAERVELDT SHUNT

FDA Adverse Event
Injury ·ABBOTT MEDICAL OPTICS·Product code KYF·September 4, 2012

BAERVELDT SHUNT

FDA Adverse Event
Injury ·ABBOTT MEDICAL OPTICS·Product code KYF·September 5, 2012

BAERVELDT SHUNT

FDA Adverse Event
Injury ·ABBOTT MEDICAL OPTICS·Product code KYF·September 5, 2012

BAERVELDT SHUNT

FDA Adverse Event
Injury ·ABBOTT MEDICAL OPTICS·Product code KYF·September 4, 2012

BAERVELDT SHUNT

FDA Adverse Event
Injury ·ABBOTT MEDICAL OPTICS·Product code KYF·September 4, 2012

ATTAIN ABILITY

FDA Adverse Event
Malfunction ·MPRI·Product code OJX·February 11, 2013

PRECISION XTRA

FDA Adverse Event
Malfunction ·Product code NBW·January 10, 2011

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 24, 2014

BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.

FDA Enforcement
Class II ·Ongoing·Biointellisense Inc.·August 21, 2024