29 results
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23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Brainsway Deep (DTMS) System
FDA 510(k)
FDA Class 2
·Neurology
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169600102·TRIAL 2173540 O25 IB 20MM 18 DEG 16X40
CARDINAL HEALTH
FDA UDI
Cardinal Health 200, LLC·10887488481050·LP RADIOLOGY TRAY
PSORIA-LIGHT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ATLANTIS ABUTMENT IN ZIRCONIA FOR BIOHORIZONS IMPLANT
FDA 510(k)
FDA Class 2
·Dental
REFOBACIN BONE CEMENT R 1X40-3
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code MBB·March 30, 2026
REFOBACIN BONE CEMENT R 1X40-3
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code MBB·February 24, 2026
5.0MM TI W/ MAXBRAID NDLS
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HWC·February 9, 2022
OPTIPAC 80 REFOB PLUS BONE CMT-3
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code MBB·March 17, 2026
ACCU-CHEK ® INFORM METER
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·June 17, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 23, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 15, 2014
REFOBACIN BONE CEMENT R 2X40G
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code MBB·March 12, 2026
REFOBACIN BONE CEMENT R 2X20-3
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code MBB·February 11, 2026
REFOBACIN BONE CEMENT R 2X40G
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code MBB·February 20, 2026
OPTIPAC 80 REFOB BONE CMT R-3
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LOD·November 14, 2025
Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IP2.P 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
REFOBACIN BONE CEMENT R 1X40-3
FDA Adverse Event
Death
·BIOMET FRANCE S.A.R.L.·Product code MBB·December 15, 2025
REFOBACIN BONE CEMENT R 1X40-3
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code MBB·December 30, 2024
REFOBACIN BONE CMNT R 1X40 JP
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code MBB·May 7, 2025