35 results
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35ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CELL-DYN 22 PLUS CONTROL
FDA 510(k)
FDA Class 2
·Hematology
Vatech Clismile
FDA UDI
Rayence Co., Ltd.·08800018600924·This product is a orthodontic bracket and is us...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0112110·Tap, Cannulated, 4.75 mm
iTotal Identity CR
FDA UDI
Conformis, Inc.·M572TCR1011112111·ITOTAL IDENTITY CR FEMORAL IMPLANT (COCR, CEMEN...
Sterile Sphincterotome
FDA UDI
Micro-Tech (Nanjing) Co., Ltd.·06932503513043·Sterile Sphincterotome, lumen 3, TIP length 5, ...
Sterile Sphincterotome
FDA UDI
Micro-Tech (Nanjing) Co., Ltd.·06932503513197·Sterile Sphincterotome/ lumen 3/ TIP length 2/ ...
iTotal Identity PS
FDA UDI
Conformis, Inc.·M572TPS1011112111·ITOTAL IDENTITY PS FEMORAL IMPLANT (COCR, CEMEN...
Sterile Sphincterotome
FDA UDI
Micro-Tech (Nanjing) Co., Ltd.·06932503512213·Sterile Sphincterotome/ lumen 3/ TIP length 2/ ...
Sterile Sphincterotome
FDA UDI
Micro-Tech (Nanjing) Co., Ltd.·06932503512237·Sterile Sphincterotome/ lumen 3/ TIP length 2/ ...
Sterile Sphincterotome
FDA UDI
Micro-Tech (Nanjing) Co., Ltd.·06932503513029·Sterile Sphincterotome, lumen 3, TIP length 5, ...
Sterile Sphincterotome
FDA UDI
Micro-Tech (Nanjing) Co., Ltd.·06932503513067·Sterile Sphincterotome, lumen 3, TIP length 5, ...
FLOWABLE COMPOSITE/ ECUFLOW/ LUXAFLOW
FDA 510(k)
FDA Class 2
·Dental
ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM ENDOSCOPIC ARTICULATING LINEAR CUTTER AND RELO
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INSULIN PUMP
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code LZG·December 2, 2016
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code LZG·December 2, 2016
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·October 2, 2019
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code LZG·November 16, 2016
T:SLIM X2 INSULIN PUMP
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code LZG·December 8, 2016
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code LZG·December 23, 2015
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·February 4, 2022