13 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NuVent EM Sinus Dilation System
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
VT Sure
FDA UDI
PULMODYNE INC·00841470105976·
Simpact Tri-Fin
FDA UDI
Life Spine, Inc.·00190837062743·Depth Gage / Alignment Guide
ENDURANCE
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295057253·FEMORAL STEM 12/14 TAPER ENDURANCE HIP STEM SIZ...
Liner Impactor
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215039318·
GEM PREMIER 3000
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ECLIPSE VERTEBRAL SPACER SYSTEM-LUMBAR
FDA 510(k)
FDA Class 2
·Orthopedic
STERLING?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·October 8, 2014
PELVICOL ACELLULAR COLLAGEN MATRIX
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTL·May 24, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011
DETERMINE HIV-1/2 AG/AB COMBO
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MZF·July 20, 2021
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
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024