215 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QUANTUM DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Gyrus ACMI
FDA UDI
Gyrus ACMI, LLC·00821925033429·EAR SUCTION NEEDLE W/BYPASS 18 GAUGE DISPOSABLE
LINK Instruments - Chisel, bone curette, raspatory, rongeur
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575234073·Orthopaedic prosthesis instrument, reusable - G...
RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SHILEY FLEXTRA TRACHEOSTOMY TUBE
FDA 510(k)
FDA Class 2
·Anesthesiology
VERCISE? CARTESIA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code NHL·May 15, 2025
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·May 24, 2013
UNIFY ASSURA DR CRT-D
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·September 30, 2014
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 16, 2011
SLEEK OTW PTA CATHETER
FDA Adverse Event
Injury
·CLEARSTREAM TECHNOLOGIES LTD.·Product code DQY·December 13, 2023
Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants and children.
FDA Enforcement
Class II
·Terminated·Medical Components, Inc dba MedComp·June 15, 2016
Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants and children.
FDA Recall
Terminated
·Medical Components, Inc dba MedComp·Product code DYB·May 5, 2016
ROCHESTER MEC WIDEBAND M 30BX
FDA Adverse Event
Injury
·ROCHESTER MEDICAL CORP 2130787·Product code NNX·October 14, 2016
INTERMITTENT MAGIC3
FDA Adverse Event
Injury
·ROCHESTER MEDICAL CORP 2130787·Product code KOD·September 10, 2015
ROCHESTER MAGIC3 COUDE HYDROPHLIC 14FR MALE 30BX
FDA Adverse Event
Malfunction
·ROCHESTER MEDICAL CORP 2130787·Product code KOD·October 6, 2016
ROCHESTER MEC ULTRAFLEX M 30BX
FDA Adverse Event
Malfunction
·ROCHESTER MEDICAL CORP 2130787·Product code NNX·November 17, 2016
INTERMITTENT MAGIC3
FDA Adverse Event
Death
·ROCHESTER MEDICAL CORP 2130787·Product code KOD·August 20, 2015
INTERMITTENT MAGIC3
FDA Adverse Event
Injury
·ROCHESTER MEDICAL CORP 2130787·Product code KOD·September 10, 2015
INTERMITTENT MAGIC3
FDA Adverse Event
Injury
·ROCHESTER MEDICAL CORP 2130787·Product code KOD·September 1, 2015
INTERMITTENT MAGIC3
FDA Adverse Event
Injury
·ROCHESTER MEDICAL CORP 2130787·Product code KOD·August 20, 2015