18 results · 22ms · Sources: EU EUDAMED, US FDA

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ACR Screw System

FDA 510(k)
FDA Class 2 ·Dental

ORTHOCORD HEALIX TI

FDA UDI
Medos International Sàrl·10886705007912·HEALIX Ti Anchor w/ORTHOCORD Titanium Anchor (1...

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172970478·

Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw Planning

FDA 510(k)
FDA Class 2 ·Neurology

G-FERT, MODEL 10033

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

NA

FDA UDI
Exactech, Inc.·10885862282880·TRIAL, MONOBLOC REVISION STEM, 22x245mm

N/A

FDA UDI
Exactech, Inc.·10885862659996·Trial, Monobloc Revision Stem

INSYTE AUTOGUARD

FDA Adverse Event
BD INFUSION THERAPY SYSTEMS, INC.·Product code FOZ·October 28, 2008

MINICAP

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·August 24, 2011

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 12, 2013

BD¿ PRN ADAPTER

FDA Adverse Event
Malfunction ·BD (SUZHOU)·Product code FOZ·June 20, 2023

BD¿ PRN ADAPTER

FDA Adverse Event
Malfunction ·BD (SUZHOU)·Product code FOZ·June 20, 2023

GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

FDA Adverse Event
Malfunction ·COOK INC·Product code MMX·August 20, 2024

COPAN WASP/COLIBRI

FDA Adverse Event
Other ·COPAN WASP·Product code QQV·July 25, 2024

BD PRN ADAPTOR

FDA Adverse Event
Malfunction ·BD (SUZHOU)·Product code FPA·June 16, 2023

GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

FDA Adverse Event
Malfunction ·COOK INC·Product code MMX·November 18, 2024

Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

Model Number L111, ESSENTIO DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025