10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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B-D SAFE-CLIP
FDA 510(k)
FDA Class 2
·General Hospital
BD SAFE-CLIP¿ NEEDLE CLIPPING & STORAGE DEVICE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·September 25, 2019
SHARPS DISPOSAL
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·August 16, 2019
APEX-DL Spine System
FDA 510(k)
FDA Class 2
·Orthopedic
Deka Bluebeam
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACRYSOF IQ TORIC
FDA Adverse Event
Other
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·December 16, 2010
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·February 5, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 18, 2014
PKG, 5MM, 45CM, INSERT, FENESTRATED FORCEPS, P/N 0250080732 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020