30 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Digital Intraoral X-Ray Sensor
FDA 510(k)
FDA Class 2
·Dental
Zavation
FDA UDI
Zavation LLC·00197157002879·CIF 14x18, 8 deg, -11
Sonolith Carbon Fiber Table
FDA UDI
EDAP-TMS FRANCE·03661690000083·One piece carbon fiber table for use with SONOL...
Lumbar IBFD
FDA UDI
KEOS·B084KPS12308110·
Lumbar IBFD
FDA UDI
KEOS·B084KPS22308110·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167312308110·
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167322308110·
PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
COOL CURE
FDA 510(k)
FDA Class 2
·Dental
MPACT ACETABULAR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·January 23, 2026
SOLUSET 150 X 60 BURETTE SET, LATEX FREE
FDA Adverse Event
Malfunction
·HOSPIRA DE COSTA RICA LTD.·Product code FPK·November 6, 2008
UNK
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 23, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 13, 2024
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 13, 2025
MPACT ACETABULAR SYSTEM IMPLANTS
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LPH·November 5, 2025
MPACT ACETABULAR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·December 18, 2025
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
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 27, 2025
AMISTEM-P COLLARED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 14, 2025