215 results · 22ms · Sources: EU EUDAMED, 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