14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Arthrex Fracture Plates
FDA 510(k)
FDA Class 2
·Orthopedic
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100226·THORLAKSON ASPIRATING SPECULUM
MaxFuse,VBR, 12 (D) x 14 (W) x 22 (H)
FDA UDI
Pioneer Surgical Technology, Inc.·00846468056063·12 (D) x 14 (W) x 22 (H)
ENDOSCOPIC APPLICATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ASTRA TECH IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
CONTOUR® NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code JJX·September 4, 2025
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 7, 2013
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 6, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·February 26, 2014
S-ROM M HEAD 36MM +0
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·February 26, 2014
CONTOUR® PLUS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code JJX·February 20, 2025
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
Medical Linear Accelerator
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 14, 2016