14 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Manual Wheelchair
FDA 510(k)
FDA Class 1
·Physical Medicine
KIWI
FDA Adverse Event
Malfunction
·LABORIE MEDICAL TECHNOLOGIES·Product code HDB·January 3, 2024
PSA4000 EEG MONITOR WITH FRONTAL PSI
FDA 510(k)
FDA Class 2
·Neurology
DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03)
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 13, 2025
GALILEO® LOCKING TOOL
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HSB·October 16, 2024
BARRIGEL INJECTABLE GEL
FDA Adverse Event
Malfunction
·PALETTE LIFE SCIENCES·Product code OVB·June 24, 2024
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 31, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 23, 2011
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP·Product code LLZ·July 8, 2013
BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BC
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·August 21, 2018
Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
FDA Enforcement
Class I
·Ongoing·Abbott Vascular·May 25, 2022
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024