19 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEMCON DENTAL DRESSING, 1 DRESSING, 4 DRESSING, 1 DRESSING, BOX OF 12, 4 DRESSING, BOX OF 12
FDA 510(k)
FDA Unclassified
·Unknown
ETEST MEROPENEM
FDA 510(k)
FDA Class 2
·Microbiology
MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
XIA LP POLYAXIAL SCREW 6.5 X 40MM
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code KWQ·September 20, 2011
XIA ROD DIA. 6 X 480
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code KWQ·June 2, 2011
XIA BLOCKER
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code KWQ·May 2, 2011
VANGUARD COMPLETE KNEE CRUCIATE RETAINING POROUS & HA FEMUR LEFT 75MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code MBH·December 16, 2016
XIA SCREW 6, 5 X 40
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code MNI·May 11, 2011
AGILIS¿NXT STEERABLE INTRODUCER DUAL-REACH¿
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC.·Product code DYB·March 29, 2024
XIA LP POLYAXIAL SCREW 5.5 X 45MM
FDA Adverse Event
Injury
·STRYKER SPINE-SWITZERLAND·Product code KWP·September 7, 2016
XIA POLYAXIAL SCREW 8.5 X 40MM
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code MNH·May 2, 2011
XIA BLOCKER
FDA Adverse Event
Injury
·STRYKER SPINE BORDEAUX·Product code KWP·May 11, 2011
EZ-28 DELIVERY SYSTEM
FDA Adverse Event
Injury
·BAUSCH & LOMB·Product code MSS·April 11, 2013
UNKNOWN DEPUY ASR CUP SIZE 50
FDA Adverse Event
Injury
·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code KWA·September 4, 2014
ONE TOUCH ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·June 17, 2008
XIA LP POLYAXIAL SCREW 6.5 X 50MM
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code KWQ·September 20, 2011
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022