14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MINAMO
FDA 510(k)
FDA Class 2
·Cardiovascular
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776396756·Volkman Retractor 4 1/2", 3 prongs blunt, ring ...
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780182016·Integra® Jarit® Volkman Retractor, 4-5/8", 3 Pr...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306804212·Kleiner-Kutz Skin Hook, Single Prong, 16cm
CHLORAPREP ONE STEP
FDA Adverse Event
Malfunction
·CAREFUSION 213, LLC 0113·Product code KXF·August 18, 2021
ASCENSION ANKLE FUSION PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 19, 2025
MONACO
FDA Adverse Event
Malfunction
·ELEKTA INC.·Product code MUJ·July 28, 2021
LAP BAND
FDA Adverse Event
Injury
·ALLERGEN·Product code LTI·October 14, 2014
CLINITEK STATUS
FDA Adverse Event
Other
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code KQO·June 18, 2013
BEAD BLOCK
FDA Adverse Event
Injury
·BIOCURE, INC.·Product code HCG·May 9, 2008
MONACO
FDA Adverse Event
Malfunction
·ELEKTA INC·Product code MUJ·August 25, 2021
Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024