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

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STARPACS DENTAL

FDA 510(k)
FDA Class 2 ·Radiology

PYRAMESH® Implant System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000855703·MESH 9051715 PYRAMESH IMP 17MMX22MMX15MM

PYRAMESH® Implant System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00681490484541·MESH 9051715 PYRAMESH IMP 17MMX22MMX15MM

MACROPORE IB RESORBABLE PLUG

FDA 510(k)
FDA Class 2 ·Orthopedic

POWDERED PATIENT EXAMINATION GLOVES, LATEX

FDA 510(k)
FDA Class 1 ·General Hospital

PEN NDL 32G 4MM 90 CT MAIL ORDER ONLY

FDA Adverse Event
Malfunction ·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·April 29, 2025

PEN NDL 32G 4MM 90 CT MAIL ORDER ONLY

FDA Adverse Event
Malfunction ·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·April 29, 2025

PEN NDL 32G 4MM 90 CT MAIL ORDER ONLY

FDA Adverse Event
Malfunction ·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·April 29, 2025

CELL-DYN DILUENT/SHEATH

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKL·January 5, 2007

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 10, 2013

ACCU-CHEK AVIVA TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS CORP.·Product code LFR·May 19, 2008

EASYTRAK 2

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code OJX·April 12, 2011

560BC BIO CONSOLE

FDA Adverse Event
Malfunction ·PERFUSION SYSTEMS·Product code DWA·June 17, 2024

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE, REF IAP-0500 (IPN000320), cardiac pump

FDA Enforcement
Class I ·Ongoing·ARROW INTERNATIONAL Inc.·December 21, 2022

CELL-DYN RUBY SYSTEM

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code GKZ·November 10, 2023

Cocoon Convective Warming System, Product Code: CWS4000 (110V).

FDA Enforcement
Class II ·Terminated·Care Essentials Pty., Ltd.·February 12, 2020