23 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LASERSKIN DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001508·artVeneer life upper anteriors, IXL, D4
Fungal Serology
FDA UDI
MICROBIOLOGICS INC.·10634853000152·Immunodiffusion Agar Plates, 8 - 7 Well Pattern
Scanlan® VASCU-STATT® approximator single-use bulldog clamp
FDA UDI
SCANLAN INTERNATIONAL INC·00846159023985·Scanlan® VASCU-STATT® approximator single-use b...
LEONE SPA
FDA UDI
LEONE SPA·08033707071457·MINI ORTHODONTIC IMPLANT LOW D1,5 L8 mm
LEONE SPA
FDA UDI
LEONE SPA·08033707071464·MINI ORTHODONTIC IMPLANT HIGH D1,5 L8 mm
THERMOFLEX SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921
FDA 510(k)
FDA Class 2
·General Hospital
VERCISE GENUS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·September 8, 2023
ACUSON SEQUOIA ULTRASOUND SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHINEERS·Product code IYN·July 26, 2024
ACUSON SC2000 ULTRASOUND SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHINEERS·Product code IYN·July 26, 2024
SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MQP·July 3, 2018
iBOT PMD with software version 01.05.24. Personal Mobility Device.
FDA Enforcement
Class II
·Ongoing·Mobius Mobility LLC·June 18, 2025
ACUSON SEQUOIA ULTRASOUND SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHINEERS·Product code IYN·July 26, 2024
VERCISE GENUS?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code MHY·July 18, 2025
CD HORIZON
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·March 15, 2017
OPTETRAK
FDA Adverse Event
Other
·EXACTECH, INC.·Product code HSH·March 5, 2013
ZIPWIRE HYDROPHILIC GUIDEWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code DQX·February 25, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·February 20, 2008
MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market.
FDA Recall
Terminated
·Codman & Shurtleff, Inc.·Product code LKK·November 10, 2015