11 results · 18ms · Sources: EU EUDAMED, US FDA

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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