21 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Clear Bi-Light
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE
FDA 510(k)
FDA Class 2
·Neurology
BONOS R GENTA 1X20 MODEL 01-0228; BONOS R GENTA 2X20 MODEL 01-0229; BONOS R GENTA 1X40 MODEL 01-0217; BONOS R GENTA 2X40
FDA 510(k)
FDA Class 2
·Orthopedic
Widex
FDA UDI
Widex A/S·05706069819144·Widex UNIQUE U-FS (Tan silk ) 100, Telecoil, RC...
Widex
FDA UDI
Widex A/S·05706069793048·Widex UNIQUE U-PA (Tan silk ) 100, RC coil
AXIOS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 18, 2024
AXIOS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·February 19, 2025
ORS-100N SOLUTION WARMER DRAPE
FDA Adverse Event
Malfunction
·MICROTEK DOMINICANA, S.A.·Product code LHC·June 16, 2016
AXIOS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 17, 2024
ECOLAB
FDA Adverse Event
ECOLAB·Product code LHC·June 17, 2016
ECOLAB
FDA Adverse Event
ECOLAB·Product code LHC·June 17, 2016
AXIOS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·February 20, 2025
AXIOS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 18, 2024
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 7, 2011
G SERIES DR
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code DXY·June 8, 2013
EXPEDIUM SINGLE INNIE SETSCREW
FDA Adverse Event
Injury
·DEPUY SPINE, INC.·Product code KWP·September 8, 2008
Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 4mm(H) Item: IWTH54 Dental implants
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 24, 2016
AXIOS?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 18, 2024
AXIOS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 27, 2024
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023