11 results
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18ms
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Sources: EU EUDAMED, US FDA
HUMAN BETA-2 MICROGLOBIN EN-RID KIT
FDA 510(k)
FDA Class 2
·Immunology
Padlock Clip-12
FDA UDI
APONOS MEDICAL CORPORATION·00864345000015·Endoscopic Ligation Clip
Padlock Clip Pro-Select
FDA UDI
US Endoscopy·00724995184254·The Padlock Clip Pro-select is used in flexible...
Padlock Clip Pro-Select
FDA UDI
US Endoscopy·00816765013809·The Padlock Clip Pro-select is used in flexible...
BIOSCREW XTRALOK
FDA 510(k)
FDA Class 2
·Orthopedic
LIASYS 450
FDA 510(k)
FDA Class 2
·Clinical Chemistry
COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·December 2, 2010
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·January 14, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 3, 2014
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015