47 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System
FDA 510(k)
FDA Class 2
·Orthopedic
NuVasive
FDA UDI
Nuvasive, Inc.·00195377106063·NTS Dilator, 16mm
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193114361·HA PEEK EVOS Straight, ,16mmx11mmx 26mm , FLAT ...
Bard Stinger Ablation Catheter: Item Numbers 210001 218501 L210001 210002 218502 L210002 210003 218503 L210003 210004 218504 L210004 210005 218505 L210005 210006 218506 L210006 210007 218507 L210007 210015 218516 L210008 210016 218518 L210009 210017 218519 L210010 210018 218520 L210011 210019 218521 L210012 210020 218523 L210013 210023 218524 L210014 210024 218525 L210015 210025 218526 L210016 210026 218527 L210017 210027 218528 L210018 210028 218529 210029 210030
FDA Recall
Terminated
·C. R.Bard, Inc./Electrophysiology Division·January 8, 2003
Stimulator, Bone Growth, Non-Invasive
FDA Pre-Market Approval
FDA Class 2
·ManaFuse
EXPLOR
FDA UDI
Biomet Orthopedics, LLC·00880304210288·
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036033934·
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100160·Compressor, Canoe
TriplePlay
FDA UDI
DYMEDIX DIAGNOSTICS, INC.·00817377020896·FM1 - Embla
Mariner
FDA UDI
Seaspine Orthopedics Corporation·10889981140717·Mariner Tray, 6.0mm Pre-Contoured Rod Caddy
MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER
FDA 510(k)
FDA Class 2
·Anesthesiology
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
FDA 510(k)
FDA Class 1
·General Hospital
GMK REVISION TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 26, 2025
GMK-HINGE FIXED TIBIAL INSERT SIZE 5/17MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·October 18, 2023
GMK HINGE AND REVISION TINBN COATED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 7, 2025
GMK HINGE AND REVISION TINBN COATED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 18, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 5, 2025
GMK-HINGE FIXED TIBIAL INSERT SIZE 4/12MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·March 22, 2024
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·June 27, 2013
OPTISENSE
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DTB·January 13, 2014