15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ESPE KETAC-CEM RADIOPAQUE
FDA 510(k)
FDA Class 2
·Dental
SEWON DENTAL FLOSS FOLDER
FDA 510(k)
FDA Class 1
·Dental
STERILE HICHMAN/BROVIAC INJECTION CAP
FDA 510(k)
FDA Class 2
·General Hospital
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 15, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·November 2, 2012
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·September 23, 2010
HLS SET ADVANCED
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code DTZ·April 29, 2021
HLS SET ADVANCED
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code DTZ·April 26, 2021
QUADROX-ID ADULT O.FILT
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code DTZ·October 30, 2021
HLS SET ADVANCED
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code DTZ·April 29, 2021
HLS SET ADVANCED 7.0
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code DTZ·July 15, 2021
HLS SET ADVANCED 7.0
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code DTZ·January 14, 2022
Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.
FDA Enforcement
Class II
·Ongoing·Genesee BioMedical, Inc.·June 6, 2018
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025