14 results · 20ms · Sources: EU EUDAMED, US FDA

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GII QUICKANCHOR PLUS

FDA 510(k)
FDA Class 2 ·Orthopedic

Harvard Ionoglas Cem Universal

FDA UDI
Harvard Dental International GmbH·EHAR70411151·Classical glass ionomer luting cement

Arthrex®

FDA UDI
ARTHREX, INC.·00888867522473·Cannulated Canc Screw,36mm Thd,7.0x115mm

AOS CANNULATED CANCELLOUS SCREW, 36mm THREAD 7.0mm x 115mm

FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665010091·

ULTRA CATHETER SET

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010

FDA 510(k)
FDA Class 2 ·Ophthalmic

SENSOR

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code EZB·November 10, 2025

EBI BONE HEALING SYSTEM

FDA Adverse Event
Injury ·EBI, LLC.·Product code LOF·April 8, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·August 27, 2014

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 23, 2011

ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS

FDA Adverse Event
Malfunction ·SYNTHES SELZACH·Product code HTC·June 2, 2014

M-LNCS Y-I

FDA Adverse Event
Malfunction ·MASIMO - 40 PARKER·Product code DQA·August 12, 2017

Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automated system for clinical chemistry analysis.

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Operations, Inc.·December 12, 2012

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012