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

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JPS JuniOrtho Plating System

FDA 510(k)
FDA Class 2 ·Orthopedic

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772777587·LUMBAMED BASIC DORSAL STAY WM SILVER I

PROFYLE

FDA UDI
Stryker GmbH·07613153160045·Insertion Drill Guide

Depth gauge countersink

FDA UDI
Treace Medical Concepts, Inc.·00810111223416·Depth gauge countersink

7000 CONNECTORS

FDA UDI
HANS RUDOLPH, INC.·00817136022253·CONN 50.8OD X 28.6IDORG 7000

Hayden Medical

FDA UDI
Hayden Medical, Inc.·00840319742495·Pennington Septum Elevator 8-1/4" (20.6cm), dou...

SCANLAN®

FDA UDI
SCANLAN INTERNATIONAL INC·00846159007589·SCANLAN® Aortic Aneurysm Clamp

Sonoma™

FDA UDI
Seaspine Orthopedics Corporation·10889981050863·Sonoma Anterior Cervical Plate 2 Level Plate, 46mm

RADIOCAMERAS EXTRACRANIAL SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH IMIPENEM (0.25, 1-32 UG/ML)

FDA 510(k)
FDA Class 2 ·Microbiology

Manta Ray™

FDA UDI
Seaspine Orthopedics Corporation·10889981057138·Plate - 2 Level - 46 mm

MODULUS-STRUMENTO-ESTRATTORE

FDA Adverse Event
Malfunction ·LIMACORPORATE S.P.A.·Product code JDI·August 9, 2022

FEMORAL MODULAR HEAD - L Ø36MM

FDA Adverse Event
Injury ·LIMACORPORATE S.P.A.·Product code LPH·August 9, 2022

FUSION QUATTRO EXTRACTION BALLOON

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code GCA·December 10, 2024

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

TANDEM T:SLIM INSULIN DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·October 22, 2014

PRIMEADVANCED

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 1, 2013

AXS VECTA 074 CATH 132CM - CE

FDA Adverse Event
Injury ·STRYKER NEUROVASCULAR-CALIF·Product code QJP·July 24, 2024

FUSION QUATTRO EXTRACTION BALLOON

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code GCA·June 7, 2024

Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

FDA Enforcement
Class II ·Terminated·Bayer Corp·June 11, 2014