59 results · 22ms · Sources: EU EUDAMED, US FDA

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ALLIANCE MEDICAL CORPORATION REPROCESSED COMPRESSION SLEEVES

FDA 510(k)
FDA Class 2 ·Cardiovascular

Advance

FDA UDI
Microport Orthopedics Inc.·M684K00600911·

InSePtion MIS Fixation System

FDA UDI
Kalitec Direct LLC·B07314K0600110·Tray Insert, ISP, Implant

MATIRA ANTERIOR CERVICAL SYSTEM

FDA UDI
Kalitec Direct LLC·B07307K0600010·Tray Insert, Level 1

Ocata Anterior Cervical System

FDA UDI
Kalitec Direct LLC·B07308K0600010·Tray Insert 1, Ocata

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K0600110·Tray Insert, Lumbar Instruments, 3

EEG WITH VIDEO, MODEL EX-NW

FDA 510(k)
FDA Class 2 ·Neurology

DURACON SYMMETRIC METAL-BACKED PATELLAR COMPONENT

FDA 510(k)
FDA Class 2 ·Orthopedic

TRIAGE TOX DRUG SCREEN PANEL

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code DIO·March 27, 2017

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 12, 2026

TRIAGE TOX DRUG SCREEN PANEL

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code DIO·May 23, 2017

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 6, 2026

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 2, 2026

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 6, 2026

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026

TENSION FREE VAGINAL TAPE

FDA Adverse Event
Injury ·ETHICON, INC.·Product code FTL·April 16, 2013