19 results · 26ms · Sources: EU EUDAMED, US FDA

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Surgical and Prosthetic Trays

FDA 510(k)
FDA Class 2 ·General Hospital

HBS HEADLESS BONE SCREW

FDA 510(k)
FDA Class 2 ·Orthopedic

AMBIENT TURBOFLASH 90 IFS

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

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

TRANSFX EXTERNAL FIXATION SYSTEM DRILL BIT QUICK-CONNECT

FDA Adverse Event
Malfunction ·ZIMMER, INC.·Product code LXH·October 31, 2008

EXTENSION SET

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·August 23, 2011

GYNECARE TVT OBTURATOR SYSTEM

FDA Adverse Event
Injury ·ETHICON INC.·Product code OTN·July 11, 2013

Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

FDA Enforcement
Class II ·Terminated·Stryker GmbH·June 24, 2020

INTELLAMAP ORION?

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

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

Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 7, 2024

BD INTIMA-II¿ CATHETER 24G X 0.75IN (Y CONNECTOR END CAP, PRN)

FDA Adverse Event
Malfunction ·BD (SUZHOU)·Product code FOZ·July 15, 2023

INTELLAMAP ORION

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

Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 7, 2024