14 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MILAGRO INTERFERENCE SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
Simpliciti™
FDA UDI
TORNIER, INC.·00846832004836·
Tornier Simpliciti® Shoulder System
FDA UDI
TORNIER, INC.·00846832090549·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970546·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970553·
SOAKER CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
EASYPROPHY SERIES AIR POLISH DEVICES, MODELS EASYPROPHY 200 AND EASYPROPHY 400
FDA 510(k)
FDA Class 1
·Dental
MAYFIELD MODIFIED SKULL CLAMP
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES CORPORATION OH/USA·Product code HBL·October 11, 2012
ADVANTAGE SERIES 29 OBS10/04
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·May 21, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 26, 2014
JAMSHIDI (TJ) NEEDLE BONE MARROW 8GX4
FDA Adverse Event
Injury
·CAREFUSION·Product code FCG·June 14, 2011
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·November 25, 2024
9NM TORQUE LIMITER SET SCREWDRIVER
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LXH·December 23, 2015
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024