23 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EVOLVE EPS ORTHOLOC
FDA 510(k)
FDA Class 2
·Orthopedic
PGI
FDA UDI
Nuvasive, Inc.·00887517419590·PGI Curette, Straight
OsteoMed
FDA UDI
OSTEOMED LLC·00845694025850·Genio Plate, 10mm, Rigid
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120342·Guidewire 1.4x100mm Sgl Trocar
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450172117·
M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000
FDA 510(k)
FDA Class 2
·Cardiovascular
ENA EIA KIT RANGE
FDA 510(k)
FDA Class 2
·Immunology
ELECTRONIC GAS BLENDER
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DTX·November 19, 2025
STOCKERT S3 GAS BLENDER
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·December 22, 2014
DEPUY ASR XL FEM IMP SIZE 43
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·May 8, 2013
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·May 16, 2011
PROXIMATE RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT, 100 MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC (CINCINNATI)·Product code GDW·August 5, 2008
S3 GAS BLENDER SYSTEM
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DTX·October 16, 2017
S3 GAS BLENDER SYSTEM
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DTX·October 16, 2017
S3 ELECTRONIC GAS BLENDER
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DTX·December 19, 2024
SORIN S3 GAS BLENDER
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND·Product code DTX·February 25, 2015
Separation Technology Creamatocrit Plus, Catalog Number: 100-146
FDA Recall
Terminated
·Product code QEI·March 16, 2022
Professional Urine Drug Control, Item code 88010 - Product Usage: The Alere Professional Cup Urine Drug Controls are compatible with all quantitative and qualitative drug detection procedures which are sufficiently sensitive to detect the control constituents.
FDA Enforcement
Class II
·Terminated·Cardinal Health Inc.·May 27, 2020
Separation Technology Creamatocrit Plus, Catalog Number: 100-146
FDA Enforcement
Class II
·Terminated·Stanbio Laboratory, LP·April 20, 2022
WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NGV·July 12, 2022