13 results
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27ms
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Sources: EU EUDAMED, US FDA
GENTAMICIN FPIA REAGENT SET AND CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Xcaliber Bone Screws
FDA UDI
ORTHOFIX SRL·18054242515944·SELF DRILLING XCALIBER CYLINDRICAL SCREW SHAFT ...
Solstice Occipito-Cervico-Thoracic System
FDA UDI
Life Spine, Inc.·00190837024819·SOLSTICE Polyaxial Screw Assembly 3.5mm x 50mm
Xcaliber Bone Screws
FDA UDI
ORTHOFIX SRL·18054242518587·SELFDRILLING XCALIBER CYLINDRICAL SCREW SHAFT D...
KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AMPLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL M100
FDA 510(k)
FDA Class 2
·Cardiovascular
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND·Product code CBK·April 30, 2014
2.7MM LCP(TM) CONDYLAR PLATE 7 HOLES SHAFT
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·February 5, 2013
PUMP IN STYLE ADVANCED
FDA Adverse Event
Other
·MEDELA, INC.·Product code HGX·December 3, 2010
UNKNOWN KNEE TIBIAL INSERT
FDA Adverse Event
Injury
·DEPUY IRELAND - 9616671·Product code JWH·April 21, 2025
UNKNOWN BONE CEMENT
FDA Adverse Event
Injury
·DEPUY IRELAND - 3015516266·Product code LOD·April 21, 2025
PKG, CLAW FORCEPS, P/N 0250080244. 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
XP-XP Tibial Tray - Interlok 73 mm Item # 195756
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019