13 results
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36ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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i_ Field 1.5T Superconducting Magnetic Resonance Imaging System
FDA 510(k)
FDA Class 2
·Radiology
FareTec PST
FDA UDI
FARETEC, INC.·B54122210250·FareTec PST Tactical, black, soft case
LEONE SPA
FDA UDI
LEONE SPA·08033707066217·PREFORMED LIGATURE WIRE 010"
J & J INSTRUMENTS
FDA UDI
J & J INSTRUMENTS INC·00817524025439·OPERATING SCI 4.5"" S/S CVD
Best Medical International
FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365117329·
YA HORNG BLOOD PRESSURE MONITOR, YA HORNG BLOOD PRESSURE MONITOR, BLUETOOTH TRANSMISSION
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ
FDA 510(k)
FDA Class 2
·Orthopedic
Widex
FDA UDI
Widex A/S·05706069813135·Widex UNIQUE U-CIC (Light beige ) 220, Left, RC...
PROMOTE ACCEL CRT-D, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·November 3, 2014
COMPASS UNIVERSAL HINGE
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code KTT·August 23, 2011
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·July 11, 2013
BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020