13 results
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19ms
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Sources: EU EUDAMED, US FDA
EBNA ANTIBODY
FDA 510(k)
FDA Class 1
·Microbiology
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668109816·MCINTYRE ANT CHAMBER CAN 30GA ANG
Epidural Anesthesia Kit
FDA UDI
Custom Interventional Pain Management, LLC·B875170·Convenience kit no Lidocaine
G-Beam Fusion Beaming System
FDA UDI
ORTHOFIX SRL·18053504360704·G-BEAM STAINLESS STEEL FUSION BEAM L170MM D5.4M...
CANON NON-MYDRIATIC RETINAL CAMERA CR3-45NM
FDA 510(k)
FDA Class 2
·Ophthalmic
EASY-TEST CALCIUM (CA), ITEM NO. 67528/93
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·June 16, 2014
2124215-2010-18106
FDA Adverse Event
Malfunction
·GUIDANT PUERTO RICO BV·Product code NVN·October 19, 2010
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·December 13, 2012
M2A-MAGNUM PF CUP
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·February 2, 2018
M2A-MAGNUM FEMORAL HEAD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·February 2, 2018
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012