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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit

FDA 510(k)
FDA Class 2 ·Hematology

12SL ECG ANALYSIS PROGRAM

FDA 510(k)
FDA Class 2 ·Cardiovascular

PICCOLO COMPOSITE NAILING SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

INTELLAMAP ORION?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·May 12, 2026

INTELLAMAP ORION

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 15, 2025

INTELLAMAP ORION

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 29, 2026

INTELLAMAP ORION?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 17, 2026

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·October 22, 2014

ONE TOUCH LANCING DEVICE

FDA Adverse Event
Injury ·LIFESCAN INC.·Product code NBW·August 4, 2011

LIFEVEST WCD 4000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·June 18, 2013

FOGARTY HYDRAGRIP CLAMP

FDA Adverse Event
Injury ·SITE 192369-V. MUELLER/SURGICAL GROUP·Product code DXC·March 5, 1997

INTELLAMAP ORION?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·January 30, 2026

PROAQT SENSOR

FDA Adverse Event
Malfunction ·PULSION MEDICAL SYSTEMS SE·Product code DXG·August 18, 2025

INTELLAMAP ORION?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 1, 2026

INTELLAMAP ORION

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·November 21, 2024

INTELLAMAP ORION?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·February 26, 2026

PROAQT SENSOR

FDA Adverse Event
Malfunction ·PULSION MEDICAL SYSTEMS SE·Product code DXG·August 18, 2025

INTELLAMAP ORION

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·December 12, 2024

INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

FDA Adverse Event
Malfunction ·COOK ENDOSCOPY·Product code PKL·September 16, 2021