24 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ToFscan
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