12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AGXO
FDA UDI
Oticon A/S·05707131261595·H110, BTE 13 WL 100 SGR AGXO
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450294871·
Proximity
FDA UDI
ALPHATEC SPINE, INC.·00190376694962·PROXIMITY FA SELF-TAP SCREW, 3.5 x 19mm
Segmental Plating System
FDA UDI
ALPHATEC SPINE, INC.·00190376545837·SPS FA Self-Tap Screw, 3.5 x 19 mm
INVIVO DENTAL
FDA 510(k)
FDA Class 2
·Radiology
CANNULATED ARTHRORIVET AND CANNULATED RC ARTHRORIVET
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 17, 2026
KYPHX® HV-R¿ BONE CEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SPINE LLC.·Product code NDN·May 29, 2013
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·June 20, 2011
PROLIEVE THERMODILITATION SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code MEQ·August 22, 2008
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022