14 results · 23ms · Sources: EU EUDAMED, US FDA

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Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use Non-stick Bipolar Forceps

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

TITAN

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

URGENT PC STIMULATOR; URGENT PC LEAD SET

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

FUJIFILM DUODENOSCOPE MODEL ED-580T

FDA Adverse Event
Injury ·FUJIFILM CORPORATION·Product code FDT·September 5, 2023

NUTRILINE

FDA Adverse Event
Malfunction ·VYGON USA·Product code LJS·October 25, 2023

NUTRILINE

FDA Adverse Event
Malfunction ·VYGON USA·Product code LJS·October 25, 2023

FUJIFILM ENDOSCOPE

FDA Adverse Event
Malfunction ·FUJIFILM CORPORATION·Product code FDS·March 18, 2022

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

FUJIFILM DUODENOSCOPE ED-580T

FDA Adverse Event
Injury ·FUJIFILM CORPORATION·Product code FDT·March 5, 2025

SOLETRA

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROMODULATION·Product code MHY·October 1, 2008

MECHANICAL (MANUAL) WHEELCHAIR

FDA Adverse Event
JUMAO MEDICAL EQUIPMENT·Product code IOR·June 26, 2013

ENTERALITE INFINITY ENTERAL FEEDING PUMP

FDA Adverse Event
Malfunction ·MOOG MED DEVICES GROUP·Product code LZH·July 29, 2011

Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

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