26 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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Luja Coude
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NeoFuse Ti3D PLIF/TLIF
FDA UDI
XENIX MEDICAL LLC·00818345021624·Ti3D CAGE 24L x 12W x 10H
TLS 5.0
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030CK2412100·Enhanced Graft Interbody Cage 7DEG x 24L x 12W ...
NeoFuse HA Enhanced PLIF/TLIF
FDA UDI
XENIX MEDICAL LLC·00818345020542·HA CAGE 24L x 12W x 10H
3D Printed Interbody Systems
FDA UDI
Seaspine Orthopedics Corporation·10889981304157·2-Hole No-Profile Interbody, 43mm x 30mm x 12mm...
Sure Comfort
FDA UDI
ALLISON MEDICAL, INC.·00786227121055·31G x 3/16" (5mm) Single use disposable pen nee...
Meridian
FDA UDI
Seaspine Orthopedics Corporation·10889981310035·Trial Rasp, 43mm x 30mm x 12mm, 10 Deg
Ophthalmic Scissors
FDA UDI
KATENA PRODUCTS, INC.·00841668105108·TROUTMAN-CASTROVIEJO SCISSORS LEFT
Meridian
FDA UDI
Seaspine Orthopedics Corporation·10889981247447·No-Profile Interbody, 43mm x 30mm x 12mm, 10 Deg
HUDSON RCI
FDA UDI
TELEFLEX INCORPORATED·14026704743596·Comfort Flo Plus Chin Strap
HUDSON RCI
FDA UDI
TELEFLEX INCORPORATED·14026704343956·Comfort Flo Plus Chin Strap
DRILL, AO, STERILE 4, 2X340 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·September 23, 2011
QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS
FDA 510(k)
FDA Class 2
·Immunology
POWERED WHEELCHAIR, MODEL B-600
FDA 510(k)
FDA Class 2
·Physical Medicine
EXPERIENCE®
FDA UDI
Gc Orthodontics America Inc.·D78824121000201·EXRC MBT 018/UL1 17T 4A
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·September 9, 2011
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·November 10, 2014
ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
FDA Adverse Event
Death
·CORDIS NEUROVASCULAR, INC.·Product code NJE·July 22, 2013
POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TPS
FDA Adverse Event
Injury
·C.R. BARD, INC. (BASD) -3006260740·Product code LJS·January 9, 2025
Endo-Model Replacement Plateau; Item Number: 15-2835/12;
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 18, 2026