21 results
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37ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HydraDose Vaginal Suppositories
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
VERSANT REALITY
FDA UDI
FGX INTERNATIONAL INC.·00193033308059·
LEONE SPA
FDA UDI
LEONE SPA·08033707023104·CALIBRA BANDS 2ND MOLAR n.SUL 18
ELMED
FDA UDI
ELMED INCORPORATED·00198506058622·Barret Tenaculum Forceps, 7” (180mm)
HENLY CAROTID RETRACTOR
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896026810·HENLY CAROTID RETRACTOR WITH CENTER BLADE
MINI-MIDLINE EXTENDED DWELL SAFETY CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
AMERITEK SURE-POINT TRACKER SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
HENLY-CAROTID MENZOIAN RETRACTOR BLADE
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896092822·HENLY-CAROTID MENZOIAN RETRACTOR BLADE EXTRA LONG
HENLY-CAROTID MENZOIAN RETRACTOR BLADE
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896092815·HENLY-CAROTID MENZOIAN RETRACTOR BLADE EXTRA LONG
HENLY CAROTID RETRACTOR
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896026827·HENLY CAROTID RETRACTOR BLADE SMALL
HENLY CAROTID RETRACTOR
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896026834·HENLY CAROTID RETRACTOR BLADE LONG
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
FDA Adverse Event
Injury
·COSTA RICA·Product code LTI·November 12, 2008
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Injury
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·August 12, 2011
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 16, 2013
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
EVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocular lens.
FDA Enforcement
Class II
·Ongoing·Staar Surgical Company·December 13, 2023
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
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 Recall
Open, Classified
·Reflexion Medical, Inc.·Product code QVA·July 22, 2025
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021