14 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, SIZES 8MM AND 10MM
FDA 510(k)
FDA Class 2
·Orthopedic
Trulife
FDA UDI
Trulife Limited·00645517726656·First Fit External Breast Form Size 04
LEONE SPA
FDA UDI
LEONE SPA·08033707065692·INTRAORAL ELASTICS 4,5 oz 3/16" green
LINK Instruments - Trial implants and size gauges
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575427628·Orthopaedic prosthesis instrument, reusable - G...
DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DORNIR LC-1 CPAP SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
20 G X 1.16 IN. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BC
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·August 14, 2017
TRANSEND EX 014/205 SOFT TIP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC COSTA RICA·Product code DQX·April 16, 2013
MOSAIC MITRAL BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Death
·MEDTRONIC HEART VALVES, INC·Product code LWR·June 11, 2008
ASR ACETABULAR CUPS 60
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 6, 2011
FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR
FDA Adverse Event
Death
·FRESENIUS HEMOCARE GMBH·Product code LKN·August 21, 2023
FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR
FDA Adverse Event
Death
·FRESENIUS HEMOCARE GMBH·Product code LKN·August 21, 2023
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 7mm x 18mm 80 cm .014" REF PMB 4-7-18-80
FDA Recall
Terminated
·Product code FGE·January 29, 2004
Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is indicated for relaxation training and muscle re-education and prescription use.
FDA Enforcement
Class II
·Terminated·Ondamed Inc·May 16, 2018