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