13 results · 19ms · Sources: EU EUDAMED, US FDA

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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