27 results · 21ms · Sources: EU EUDAMED, US FDA

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WoundExpress

FDA 510(k)
FDA Class 2 ·Cardiovascular

PMT® Halo Systems

FDA UDI
PMT CORPORATION·00650551112143·HALO, 1203-5 VEST MEDIUM, COOLMAX LINER, 1211-1...

NA

FDA UDI
Stryker Leibinger GmbH & Co. KG·07613327359732·2.0MP LEFORT I PLATE,0MM ADVANCEMENT,L

TALOS®-C HA

FDA UDI
MEDITECH SPINE, LLC·B167522112000·

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B16721312112000·

JOBST Elvarex

FDA UDI
BSN-Jobst GmbH·04019702421088·ELVAREX 3/THIGH HIGH/SLANT-OPEN TOE-ELEPHANTIAS...

Navagio

FDA UDI
Kalitec Direct LLC·B07330K0112000·Inserter, Universal Inline Fixed

EASYPOINT

FDA Adverse Event
Malfunction ·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·June 15, 2023

EASYPOINT

FDA Adverse Event
Malfunction ·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·June 15, 2023

MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

GILB, MODEL 8010

FDA 510(k)
FDA Class 2 ·Dental

INTELLIVUE INFO CENTER IX

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·December 19, 2023

PATIENT INFORMATION CENTER IX

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·May 1, 2024

RESERVOIR 3M,L

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·July 11, 2011

MECHANICAL WALKER, ROLLATOR

FDA Adverse Event
CONSMA·Product code ITJ·October 29, 2014

LCP 4.5/5 BROAD CURV 14HO L265 SST

FDA Adverse Event
Injury ·SYNTHES GMBH·Product code KTT·July 8, 2013

8100 ALARIS PUMP MODULE

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·November 9, 2020

Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500

FDA Enforcement
Class II ·Ongoing·SEDECAL SA·November 16, 2022

GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed

FDA Enforcement
Class II ·Ongoing·GE Medical Systems, LLC·March 19, 2025

OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.

FDA Enforcement
Class II ·Ongoing·GE OEC Medical Systems, Inc·December 25, 2024