15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PediatrOS RigidTack/FlexTack
FDA 510(k)
FDA Class 2
·Orthopedic
BARRET II KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304242111·
Sklar®
FDA UDI
SKLAR CORPORATION·10649111203817·MAYO-NOBLE DISS SCISS STR 6.5"
Best Medical International
FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365118739·
MaxFuse,VBR, 12 (D) x 14 (W) x 37 (H)
FDA UDI
Pioneer Surgical Technology, Inc.·00846468056360·12 (D) x 14 (W) x 37 (H)
SAF-T-SYRINGE/SAF-T-NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
VIPER F2 FACET FIXATION SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
EQ REV GLENOID PLATE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·October 8, 2024
CONTOUR® NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code JJX·September 4, 2025
ACCU-CHEK ® SPIRIT COMBO
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code LZG·October 8, 2014
ATTAIN ABILITY
FDA Adverse Event
Injury
·MPRI·Product code OJX·June 7, 2013
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 6, 2011
AERO LL FIXATION ANCHOR, 50MM
FDA Adverse Event
Malfunction
·STRYKER SPINE-US·Product code OVD·March 25, 2019
CONTOUR® PLUS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code JJX·February 20, 2025
SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 26, 2014