8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Xenco Medical Posterior Cervical System
FDA 510(k)
FDA Class 2
·Orthopedic
STRYKER SPINE POWER ADAPTOR (ACCESSORY INSTRUMENT)
FDA 510(k)
FDA Class 2
·Orthopedic
PROCERA TITANIUM ABUTMENT FOR ASTRATECH AND CAMLOG IMPLANT SYSTEMS
FDA 510(k)
FDA Class 2
·Dental
SENSIA SR
FDA Adverse Event
Death
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·June 11, 2013
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 14, 2011
FREESTYLE FREEDOM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 11, 2008
Jackson-Pratt Silicone Round Drain, 10FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·May 31, 2017
RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014