23 results · 21ms · Sources: EU EUDAMED, US FDA

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StealthStation Cranial Software, v3.1.5 (9735585)

FDA 510(k)
FDA Class 2 ·Neurology

SnapshotNIR

FDA 510(k)
FDA Class 2 ·Cardiovascular

Contour ProtégéAI

FDA 510(k)
FDA Class 2 ·Radiology

STINGRAY LP

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·March 26, 2025

STINGRAY LP

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·February 3, 2025

STINGRAY? LP

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·May 29, 2026

INFUSOR

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·September 1, 2011

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·November 6, 2014

CUSTOM PAK

FDA Adverse Event
Malfunction ·ALCON - IRVINE TECHNOLOGY CTR·Product code KYG·July 15, 2013

SALINE/SILCONE BREAST IMPLANTS

FDA Adverse Event
Injury ·MCGHAN·Product code FTR·August 9, 1993

TRUENESS

FDA Adverse Event
Malfunction ·SINOCARE INC·Product code NBW·November 3, 2025

TRUENESS

FDA Adverse Event
Injury ·SINOCARE INC·Product code NBW·October 15, 2025

TRUENESS

FDA Adverse Event
Malfunction ·SINOCARE INC.·Product code NBW·November 28, 2025

TRUENESS

FDA Adverse Event
Injury ·SINOCARE INC ADDRESS LINE 1 NO.265 GUYUAN·Product code NBW·October 20, 2025

TRUENESS

FDA Adverse Event
Malfunction ·SINOCARE INC·Product code NBW·May 29, 2026

TRUENESS

FDA Adverse Event
Malfunction ·SINOCARE INC·Product code NBW·March 11, 2026

TRUENESS AIR

FDA Adverse Event
Malfunction ·SINOCARE INC·Product code NBW·February 26, 2026

TRUENESS

FDA Adverse Event
Malfunction ·SINOCARE INC·Product code NBW·October 20, 2025

TRUENESS

FDA Adverse Event
Malfunction ·SINOCARE INC·Product code NBW·November 19, 2025

TRUENESS

FDA Adverse Event
Malfunction ·SINOCARE INC.·Product code NBW·October 10, 2025