19 results
·
26ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set
FDA 510(k)
FDA Class 2
·General Hospital
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704285376·
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100318·ALPHONSO INFANT SPECULUM
EVEREST SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AMPLATZER SIZING BALLOON II
FDA 510(k)
FDA Class 2
·Cardiovascular
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., HU·Product code KWP·October 17, 2025
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 7, 2011
INSYNC MAXIMO
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NIK·June 8, 2013
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·October 8, 2014
CD HORIZON BALLAST SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NKB·December 9, 2019
FLEXOR SHUTTLE TIBIAL GUIDING SHEATH
FDA Adverse Event
Injury
·COOK INC·Product code DYB·October 29, 2025
FLEXOR SHUTTLE TIBIAL GUIDING SHEATH
FDA Adverse Event
Injury
·COOK INC·Product code DYB·October 29, 2025
DYB INTRODUCER, CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code DYB·November 12, 2025
FLEXOR SHUTTLE SELECT GUIDING SHEATH
FDA Adverse Event
Injury
·COOK INC·Product code DYB·October 29, 2025
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·September 15, 2020
FLEXOR SHUTTLE SELECT GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·February 7, 2020
ASAHI CONQUEST PRO 9-40
FDA Adverse Event
Malfunction
·ASAHI INTECC CO., LTD.·Product code DQX·April 27, 2016
StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures.
FDA Enforcement
Class II
·Terminated·Dental EZ Stardental Division·June 19, 2013
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023