27 results · 25ms · Sources: EU EUDAMED, US FDA

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Arrowhead Mini-Rail Fixator

FDA 510(k)
FDA Class 2 ·Orthopedic

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776116057·Pass Thru Bracket

Pinehurst Anterior Cervical Plate System

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215030674·

Aquila Anterior Cervical Plate System

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215125738·

MAGNETOM Verio Dot Upgrade. Model Number: 10684334.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

ACCUSOFT, ACCUSOFT XL

FDA 510(k)
FDA Class 2 ·Radiology

KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) - 12 STERILE PAIRS

FDA 510(k)
FDA Class 1 ·General Hospital

KYPHON XPEDE BONE CEMENT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·December 21, 2018

KYPHON XPEDE BONE CEMENT

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·May 29, 2019

KYPHON XPEDE BONE CEMENT

FDA Adverse Event
Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 28, 2019

KYPHON XPEDE BONE CEMENT

FDA Adverse Event
Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 28, 2019

1030489-2019-01511

FDA Adverse Event
Death ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NDN·December 31, 2019

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·October 10, 2014

KINECTIV TECHNOLOGY MODULAR NECK

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code LPH·July 12, 2011

STENOSCOP

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 6, 2013

1030489-2019-01423

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code NDN·December 13, 2019

CER BIOLOXD MOD HD 38MM STD NK

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LZO·August 26, 2020

CER BIOLOXD MOD HD 38MM -6 NK

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code LPH·April 8, 2020

M2A 1 PC SHELL 38MMX54MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWY·May 18, 2020

M2A-38 CUP NON FLARED SZ 52MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWA·April 8, 2020