21 results · 24ms · 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.

BIOPSY POSITIONER

FDA 510(k)
FDA Class 2 ·Radiology

CoRoent

FDA UDI
Nuvasive, Inc.·00887517564214·CoRoent Ant TLIF PEEK, 11x13x28mm 4°

Medetz Surgical Instruments

FDA UDI
Medetz Surgical Instruments LLC·G223113284220·McIntyre anterior chamber cannula, 26 gauge, 12...

LAMINOPLASY PLATING SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

LUMEND FRONTRUNNER CTO CORONARY CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

OPTICROSS HD

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·March 28, 2025

OPTICROSS? HD

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·July 7, 2025

OPTICROSS? HD

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·July 22, 2025

OPTICROSS? HD

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·February 11, 2025

OPTICROSS? HD

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·April 3, 2025

OPTICROSS? HD

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·December 11, 2025

OPTICROSS? HD

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·September 16, 2025

OPTICROSS? HD

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·January 13, 2026

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 8, 2013

ASR ACETABULAR CUPS 54

FDA Adverse Event
Injury ·DEPUY INTL., LTD.·Product code KWA·May 20, 2011

DIMENSION CLINICAL CHEMISTRY SYSTEM

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·August 8, 2008

4.5 BROAD SCP PLT 26-H STER

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

OPTICROSS? HD

FDA Adverse Event
Death ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·May 22, 2025

OPTICROSS? HD

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·February 26, 2025

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021