17 results
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33ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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QuickDraw Venous Cannula
FDA 510(k)
FDA Class 2
·Cardiovascular
STEVENS TENOTOMY SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896055148·STEVENS TENOTOMY SCISSORS LONG CURVED BLUNT TUN...
QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BOND-3 ADHESIVE
FDA 510(k)
FDA Class 2
·Dental
ADVANTA SUPER SOFT GRAFT
FDA 510(k)
FDA Class 2
·Cardiovascular
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·October 24, 2019
T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code LZG·September 25, 2019
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·April 19, 2023
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·March 10, 2020
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·August 23, 2022
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·March 26, 2025
UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code DHA·August 11, 2011
SPAREKEY F/DRILL CHUCK CLAM RANGE - Ø4
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HTW·October 24, 2014
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·July 1, 2013
IMPL SCR-V HA 4.7MM 4.5MM 13MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·November 17, 2021
ENDOWRIST;DAVINCI SI
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·September 7, 2022
Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
FDA Enforcement
Class II
·Terminated·Bayer Corp·June 11, 2014