13 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK
FDA 510(k)
FDA Class 2
·Orthopedic
Sklar
FDA UDI
SKLAR CORPORATION·30649111376850·COVER FOR 10-1738 PK/12
D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SILVER
FDA 510(k)
FDA Unclassified
·Unknown
JET-X BAR SYSTEM CLAMPS, BARS AND POSTS-MR SAFE
FDA 510(k)
FDA Class 2
·Orthopedic
T:SLIM X2 INSULIN PUMP
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code LZG·September 7, 2018
PLUM XLM W/DATAPORT
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·October 9, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 5, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 22, 2011
FLEXOR URETERAL ACCESS SHEATH AND DILATORS
FDA Adverse Event
Malfunction
·COOK INC·Product code FED·January 3, 2020
FLEXOR URETERAL ACCESS SHEATH AND DILATORS
FDA Adverse Event
Malfunction
·COOK INC·Product code FED·January 2, 2020
FLEXOR URETERAL ACCESS SHEATH AND DILATORS
FDA Adverse Event
Malfunction
·COOK INC·Product code FED·January 7, 2020
RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms
FDA Enforcement
Class II
·Terminated·Brainlab AG·January 20, 2016
RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms
FDA Enforcement
Class II
·Terminated·Brainlab AG·January 20, 2016