11 results · 28ms · Sources: EU EUDAMED, US FDA

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Radiography 7300 C

FDA 510(k)
FDA Class 2 ·Radiology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 22, 2025

SMITH & NEPHEW CANNULATED CAPTURED SCREW

FDA 510(k)
FDA Class 2 ·Orthopedic

SYNERGY SPINE ARRAY COIL

FDA 510(k)
FDA Class 2 ·Radiology

ALARIS SYSTEM

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·September 27, 2023

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code OYC·November 6, 2014

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 2, 2011

14.5MM OUTER PROTECTION SLEEVEFOR SUPRAPATELLAR - STERILE

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code JDS·July 18, 2013

BD EMERALD¿ SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·December 3, 2018

Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuration, Rev H SW-300689-02 Bigfoot Inject v1 Pen Cap RCAP Firmware 1.3.0 Release Configuration, Rev H The Bigfoot Unity Diabetes Management System that include the Pen Caps (Rapid-Acting Insulin Pen Cap [RCAP] and Long-Acting Insulin Pen Cap [LCAP]) integrates continuous monitoring with insulin dose recommendations. The Pen Caps (Rapid-Acting Insulin Pen Cap [RCAP] and Long-Acting Insulin Pen Cap [LCAP]) are part of the Bigfoot Unity Diabetes Management System.

FDA Recall
Open, Classified ·BIGFOOT BIOMEDICAL·Product code QLG·May 21, 2025

Phantom-brand Black Latex Powder Free Examination Gloves, 100 gloves by weight, size small and Medium, Product Code PHM912, Lot No. 002-E1LF302-1, Manufacture date JUL 2011, Size Small Product Code PHM915, Lot No. 002-E1LF305-1, Manufacture date JUL 2011, Size Medium Examination Disposable Gloves

FDA Recall
Terminated ·Adenna Inc·Product code LYY·December 22, 2011