16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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