8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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THEOPHYLLINE RADIOIMMUNOASSAY ARIA HT SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ASSY, PAD, CHEST, FLAT, NON-ACP
FDA UDI
MIZUHO ORTHOPEDIC SYSTEMS, INC.·00842430100789·Made with Tempur-Pedic® Medical materials.
CELL-DYN 100 WHOLE BLOOD PLATELET
FDA 510(k)
FDA Class 2
·Hematology
OP-CON SURG. INSTRUMENT #10
FDA 510(k)
FDA Class 1
·Neurology
SCORPIO NRG INSERT TRIAL #9 8MM
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LXH·June 2, 2014
UNKNOWN DEPUY ASR FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KXA·November 26, 2012
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·September 13, 2010
PKG, BULLET FORCEPS, TAPERED, SERRATED, SPOON, P/N 0250080281. 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