121 results · 26ms · Sources: EU EUDAMED, US FDA

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iTOF®

FDA 510(k)
FDA Class 2 ·Anesthesiology

Bioseal Inc.

FDA UDI
BIOSEAL·00630094024257·Gauze X-Ray Detectable

Vilex Power Accessory

FDA UDI
VILEX IN TENNESSEE, INC.·00841731122315·KWire .094 x 9" (2.4x225mm)

PK Lap Loop

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENTRICITY DIGITAL HARDCOPY WORKSTATION

FDA 510(k)
FDA Class 2 ·Radiology

JDEVOLUTION PLUS

FDA Adverse Event
Injury ·J DENTAL CARE SRL·Product code DZE·November 13, 2025

JDEVOLUTION PLUS

FDA Adverse Event
Injury ·J DENTAL CARE SRL·Product code DZE·June 23, 2025

JDICON PLUS

FDA Adverse Event
Injury ·J DENTAL CARE SRL·Product code DZE·February 4, 2026

OPTETRAK CEMENTED FINNED TIBIAL TRAY

FDA Adverse Event
Other ·EXACTECH, INC.·Product code HSH·November 21, 2008

DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 10, 2011

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 23, 2013

ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·April 8, 2026

ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·April 1, 2026

ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·April 30, 2026

ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·January 17, 2025

ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·May 4, 2026

ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·May 4, 2026

ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·April 17, 2026

ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·March 9, 2026

ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·April 8, 2026