18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Spinal Jaxx Interbody Fusion Device
FDA 510(k)
FDA Class 2
·Orthopedic
Temptation NOW® A1 8g
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172002073·Crown and Bridge Temporary Resin
Temptation NOW® A1 8g
FDA UDI
DEN-MAT HOLDINGS, LLC·00359883003883·Crown and Bridge Temporary Resin
LEONE SPA
FDA UDI
LEONE SPA·08033707014195·CALIBRA 1ST MOL BANDS W/G8325-02 n.UR 1
STINGRAY LP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQY·March 26, 2025
MULTIPLE RESIN TOOTH BONDING AGENT
FDA 510(k)
FDA Class 2
·Dental
VENUS PEARL PLT REFILL A1
FDA 510(k)
FDA Class 2
·Dental
WARMER DRAPE
FDA Adverse Event
Malfunction
·MICROTEK DOMINICANA, S.A.·Product code LHC·February 17, 2016
STINGRAY? LP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQY·May 29, 2026
PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE
FDA Adverse Event
Malfunction
·MEDELA, INC.·Product code HGX·October 6, 2014
ATTAIN ABILITY PLUS
FDA Adverse Event
Malfunction
·MPRI·Product code OJX·June 7, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 27, 2011
FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the FreeStyle Libre Flash Glucose Monitoring System
FDA Enforcement
Class I
·Ongoing·Abbott Diabetes Care, Inc.·April 12, 2023
BD SAFETYGLIDE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·August 22, 2024
BD SAFETYGLIDE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·January 23, 2024
FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the FreeStyle Libre Flash Glucose Monitoring System
FDA Recall
Open, Classified
·Abbott Diabetes Care, Inc.·Product code PZE·February 13, 2023
BD SAFETYGLIDE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·January 17, 2024
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