63 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
OptiMesh Expandable Interbody Fusion System
FDA UDI
SPINEOLOGY INC.·M7403120055·Mesh Extender
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K1100550·Caddie, Misc Screws
N/A
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K190055001·MTM® NO TRACE (TM) 018 UL/4-4
RIVA Pedicle Screw System
FDA UDI
XENIX MEDICAL LLC·00840493418810·CONSTRAINED LORDOTIC ROD, 6.0mm x 55mm
IN-OVATION® L
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K190055011·IN-OVATION® L 018 UPPER 6-6
IN-OVATION® L
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K190055101·IN-OVATION® L 018 UL/7-7
RIVA Posterior Fixation System
FDA UDI
XENIX MEDICAL LLC·00840493418605·CONSTRAINED LORDOTIC ROD, 5.5mm x 55mm
BLOOD PRESSURE METER, MODEL CH-609
FDA 510(k)
FDA Class 2
·Cardiovascular
PHILIPS INTEGRIS ALLURA 9 WITH FD OPTION
FDA 510(k)
FDA Class 2
·Radiology
TOTAL FEMUR
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE·Product code KRO·June 7, 2018
CUSTOM TOTAL FEMUR REPLACEMENT IMPLANT
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 24, 2014
ENDURO MENISCAL COMPONENT F2 22MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code KRO·December 9, 2014
ENDURO MENISCAL COMPONENT F2 10MM
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code KRO·January 14, 2015
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 20, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 25, 2014
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·May 26, 2011
CUSTOM TOTAL FEMUR REPLACEMENT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD·Product code JDI·July 24, 2015
CUSTOM TOTAL FEMORAL REPLACEMENT IMPLANT
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE LTD·Product code JDI·December 23, 2014
UNKNOWN MICROCATHETER
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code DQY·May 30, 2017