11 results
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18ms
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Sources: EU EUDAMED, US FDA
IMPALA CASTERS
FDA 510(k)
FDA Class 1
·Physical Medicine
ReLine
FDA UDI
Nuvasive, Inc.·00195377069375·RELINE C Screw, 3.5x46mm FA
Fixion Nailing System
FDA UDI
CARBOFIX ORTHOPEDICS LTD·07290109331270·Cortical screw for use with humeral nails
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613025557·Universal Wire Plate Scissors, Laterally Angled...
ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214
FDA 510(k)
FDA Class 2
·Orthopedic
INTERSTIM
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·November 12, 2010
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code LWS·July 3, 2014
CUSTOM PAK
FDA Adverse Event
Malfunction
·ALCON - HOUSTON·Product code KYG·December 21, 2012
1.85MM TI MATRIX SCREW SELF-TAPPING/4MM
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code JEY·January 21, 2015
PKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080360. 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