88 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MAGNETOM AERA AND MAGNETOM SKYRA
FDA 510(k)
FDA Class 2
·Radiology
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
Base Unit fixation plate
FDA UDI
Noras MRI products GmbH·04251269201752·
Base Unit fixation plate
FDA UDI
Noras MRI products GmbH·04251269205279·
Vatech Clismile
FDA UDI
Rayence Co., Ltd.·08800018601051·This product is an orthodontic bracket and is u...
GENESIS DM MODEL: 6053000A1
FDA 510(k)
FDA Class 2
·Cardiovascular
HUANQIU AND SUPER (TWO BRANDS) STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE
FDA 510(k)
FDA Class 2
·General Hospital
Evolve Stem
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215052034·
Evolve Stem
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215052003·
Evolve Stem
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215052058·
Evolve Stem
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215051945·
Evolve Stem
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215052072·
Evolve Stem
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215051952·
Evolve Stem
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215052010·
Evolve Stem
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215051938·
Evolve Stem
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215051990·
Evolve Stem
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215052065·
Evolve Stem
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215051969·
Evolve Stem
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215051921·