24 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Diagnostic Station DS20
FDA 510(k)
FDA Class 2
·Cardiovascular
Temptation NOW® A3 8g Bulk
FDA UDI
DEN-MAT HOLDINGS, LLC·00359883006303·Crown and Bridge Temporary Resin
Paxeon Femoral Head
FDA UDI
PAXEON RECONSTRUCTION LLC·08177570200283·Paxeon Head 40mm, CoCr Size L
Femoral Head
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215053550·
Signature Femoral Head
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215001780·
OrthoMedFlex
FDA UDI
ORTHOMEDFLEX LLC·M7161111520430·Femoral Head, 40mm +4mm (L)
CUSA EXCEL 23KHZ STANDARDTIP
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES (IRELAND) LTD.·Product code LFL·November 24, 2015
3.8MM CS FACET COMPRESSION DEVICE
FDA 510(k)
FDA Unclassified
·Unknown
ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SIGNATURE Head - CoCr
FDA UDI
AMPLITUDE SAS·03701089520706·
ATTAIN ABILITY PLUS
FDA Adverse Event
Malfunction
·MPRI·Product code OJX·June 7, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011
PERMASORB 5MM LAPAROSCOPIC 38 CM
FDA Adverse Event
Malfunction
·DAVOL INC.·Product code MAI·August 12, 2008
FLEXOR RADIAL ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·December 12, 2017
FLEXOR RADIAL ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·December 27, 2016
FLEXOR RADIAL ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·March 10, 2017
FLEXOR RADIAL ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·March 10, 2017
ProScreen 10 Panel Dip Card w/Adult, Item No. PSDA-10MO, PSDA-10MMO300, PSDA-10PPX, PSDA-10BUP, PSD-12BUP, PSD-10M, PSCupA-6MB-W, PSCup-10MMO300, PSD-5AB, PSD-10CMO3, PSCupA-10MO, PSCupA-12M-W I-DXA-1127-023, PSCupA-12TBU.
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 20, 2013
Precise Treatment Table. To be used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 17, 2013