9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH
FDA 510(k)
FDA Class 1
·Orthopedic
CD 3700 SL
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·May 23, 2007
CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PRECISION RXI ANALOG X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
CELL-DYN 3700 SL ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·February 22, 2019
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 18, 2014
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·January 29, 2013
RX HERCULINK ELITE
FDA Adverse Event
Malfunction
·ABBOTT·Product code FGE·December 17, 2010
PKG, GRASPER FORCEP, BOWEL, P/N 0250080324. 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