14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENDOBUTTON DIRECT
FDA 510(k)
FDA Class 2
·Orthopedic
Eccentric
FDA UDI
Cendres+Métaux SA·07640173090014·Eccentric
Transfer jig
(male part with resilience)
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290114692137·Final Drill for Ø6mm Implant, Short
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290114695114·Final Drill for Ø6mm Implant, Short
MIERU (ETAFILCON A) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER
FDA 510(k)
FDA Class 2
·Ophthalmic
VERTE-STACK SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OMNIGUIDE BEAMPATH FIBER AND ADAPTER
FDA Adverse Event
OMNIGUIDE, INC.·Product code GEX·October 19, 2010
S-ROM M HEAD 36MM +0
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·August 14, 2013
PINNACLE MTL INS NEUT36IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·August 14, 2013
GEMSTAR SPLT SET Y-EXT W/ BACKCHK 282CM
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·April 15, 2013
UNKNOWN DEPUY SZ5 CR RT FEMUR
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·April 25, 2011
COAGUCHEK XS SYSTEM
FDA Adverse Event
Malfunction
·RCHE DIAGNOSTICS·Product code GJS·July 3, 2008
Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
FDA Enforcement
Class II
·Terminated·Unomedical As·November 9, 2016
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012