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

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APTUS Wrist 2.5 System

FDA 510(k)
FDA Class 2 ·Orthopedic

Equator

FDA UDI
Preat Corporation·00842092182192·Equator Abutment for Astra EV 5.4 x 6mm

ACDF STAND ALONE CERVICAL

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·October 8, 2025

AMPLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL E101

FDA 510(k)
FDA Class 2 ·General Hospital

FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

ACDF STAND ALONE CERVICAL

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·April 25, 2025

SMITHS MEDICAL HYPODERMIC NEEDLE-PRO REF 4290

FDA Adverse Event
SMITHS MEDICAL ASD, INC.·Product code FMI·June 23, 2022

ACDF STAND ALONE CERVICAL

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·December 22, 2025

CS300

FDA Adverse Event
Death ·DATASCOPE CORP.·Product code DSP·May 30, 2013

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 12, 2014

ASR UNI FEMORAL IMPL SIZE 47

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 23, 2011

ACDF 03.18.118 MECTA-C SA TIPEEK CAGE 18X15X6X7°

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·May 12, 2023

ACDF STAND ALONE CERVICAL

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code OVE·June 13, 2025

BACTEC LYTIC/10 ANAEROBIC/F MEDIUM

FDA Adverse Event
Injury ·BD DIAGNOSTIC SYSTEMS·Product code MDB·January 29, 2015

Cobe CML Duo Flat Sheet Membrane Oxygenator, Non-sterile, Catalog Number: 436122974, COBE Cardiovascular, Inc..-(shipped international only for use in Heart/Lung Packs)

FDA Recall
Terminated ·Cobe Cardiovascular, Inc·Product code DTZ·June 26, 2006

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·September 21, 2022