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NDI-IKE EMG

FDA 510(k)
FDA Class 2 ·Neurology

DRIVE

FDA Adverse Event
Injury ·ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD·Product code ITJ·September 24, 2025

CLINITRON CII AIR FLUIDIZED THERAPY UNIT

FDA Adverse Event
Other ·HILL-ROM CHARLESTON·Product code INX·October 9, 2008

33110E EU DISP 10 LEAD MONITORING SET X5

FDA Adverse Event
Malfunction ·COVIDIEN·Product code IKE·April 21, 2021

RESTORE RECHARGAEBLE NEUROSTIMULATOR

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·November 24, 2008

CAPTIQUE

FDA Adverse Event
GENZYME BIOSURGERY·Product code LMH·October 18, 2005

MIDAS REX MR8

FDA Adverse Event
Malfunction ·MDT POWERED SURGICAL SOLUTIONS·Product code HBE·April 16, 2026

BYTE NIGHT ALIGNERS

FDA Adverse Event
Injury ·STRAIGHT SMILE, LLC·Product code NXC·October 30, 2024

HYDRUS MICROSTENT

FDA Adverse Event
Injury ·IVANTIS INC·Product code OGO·February 12, 2026

UNSPECIFIED BD INFUSION SET

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FPA·June 16, 2022

SYNCHROMED II

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·January 7, 2016

King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.

FDA Recall
Terminated ·King Systems Corp.·Product code CAE·December 13, 0012

RESOLUTE INTEGRITY RX

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code NIQ·June 29, 2021

ACUITY STEERABLE

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NVY·July 17, 2011

MOTOR LEGEND EHS STYLUS

FDA Adverse Event
Malfunction ·MDT POWERED SURGICAL SOLUTIONS·Product code HBE·July 1, 2025

DREAMSTATION AUTO CPAP

FDA Adverse Event
Malfunction ·RESPIRONICS, INC·Product code BZD·July 1, 2022

ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·January 6, 2020

ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·January 6, 2020

ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·January 6, 2020

ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·January 6, 2020