24 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Orthopantomograph OP 3D LX
FDA 510(k)
FDA Class 2
·Radiology
K-Systems
FDA UDI
Coopersurgical, Inc.·00888937025064·T45 Warming Plate
Handicare
FDA UDI
HANDICARE USA, INC.·00810045510187·ErgoSlide Plus II 2305
LEONE SPA
FDA UDI
LEONE SPA·08033707022978·CALIBRA BANDS 2ND MOLAR n.SUL 5
Zavation
FDA UDI
Zavation LLC·00197157002572·CIF 14x18, 5 deg, -05
Adler Instrument Company
FDA UDI
Adler, Inc.·00810123200887·PLAIN SPLINTER FCPS 4-5/8
CAPIOX CARDIOTOMY RESERVOIR
FDA 510(k)
FDA Class 2
·Cardiovascular
DORO QR3 Headrest System (Aluminum)
FDA 510(k)
FDA Class 2
·Neurology
Specials
FDA UDI
Seaspine Orthopedics Corporation·10889981302283·Lollipop Trial, Anterior-Angled, 23mm x 5mm x 5...
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 20, 2025
BD MICROLANCE¿ 3 NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·August 17, 2023
ECHELON 60 ENDOPATH STAPLER
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·November 10, 2008
PULSE GEN MODEL UNK
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·August 12, 2011
CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·July 16, 2013
BD MICROLANCE 3 CANNULAS 18 G
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·September 15, 2023
ORTHOPEDIC STEREOTAXIC INSTRUMENT
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code OLO·December 12, 2023
RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002 (01)00860003983812(11)230505(21)X11003 (01)00860003983812(11)230530(21)X11004 (01)00860003983812(11)230811(21)X11006 (01)00860003983812(11)230410(21)X11007 (01)00860003983812(11)230803(21)X11008 (01)00860003983812(11)240528(21)X11009 (01)00860003983812(11)240820(21)X11010 (01)00860003983812(11)241107(21)X11011 (01)00860003983812(11)241206(21)X11012 The RefleXion X1 is a radiation therapy system that combines the functionality of an emission computed tomography detection system and a linear accelerator. The device is intended for use with approved fludeoxyglucose F18. The emission computed tomography detection system acquires images of positron-emitting fludeoxyglucose F18 for the purpose of guiding the delivery of megavoltage X-rays for oncologic treatment with radiation therapy using an FDA cleared, authorized, or approved linear accelerator.
FDA Enforcement
Class II
·Ongoing·Reflexion Medical, Inc.·September 10, 2025
Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·December 25, 2024
RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that combines the functionality of an emission computed tomography detection system and a linear accelerator.
FDA Enforcement
Class II
·Ongoing·Reflexion Medical, Inc.·June 5, 2024
RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
FDA Enforcement
Class II
·Ongoing·Reflexion Medical, Inc.·April 8, 2026