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

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FDA 510(k)
FDA Class 2 ·Anesthesiology

Sklar®

FDA UDI
SKLAR CORPORATION·10649111355882·ROCH-OCHSNER FCP 1X2 CVD 10"

FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

HEMAWAY SEAT

FDA 510(k)
FDA Unclassified ·Unknown

M-VIZION FEMORAL REVISION SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 5, 2025

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 5, 2025

BALL HEADS: COCR 01.25.012 COCR BALL HEAD 12/14 Ø 28 SIZE M 0

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·April 14, 2023

SM204 M-SERIES W/BIG WHEEL

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·June 17, 2013

ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

FDA Adverse Event
Death ·MEDTRONIC IRELAND·Product code NIQ·July 20, 2011

TRIAGE CARDIAC PANEL

FDA Adverse Event
Malfunction ·BIOSITE INCORPORATED·Product code MMI·September 20, 2008

STEM: M-VIZION 01.22.102 DISTAL STEM 13MM L 140MM STRAIGHT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·October 1, 2021

M-VIZION FEMORAL REVISION SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·October 2, 2025

M-VIZION FEMORAL REVISION SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 21, 2024

Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.SR Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.

FDA Enforcement
Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013

M-VIZION PROXIMAL BODY Ø20MM L 70MM LAT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·August 22, 2024

MPACT ACETABULAR SHELL Ø54 TWO-HOLES

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·December 20, 2023

M-VIZION DISASSEMBLY ROD

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code LXH·April 20, 2022

1.8MM DRILL BIT WITH DEPTH MARK/QC/110MM

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code HTW·December 4, 2014

MECTACER BIOLOX OPTION HEADS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 8, 2026

M-VIZION FEMORAL REVISION SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·March 10, 2026