17 results · 33ms · Sources: EU EUDAMED, 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