24 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2)
FDA 510(k)
FDA Class 2
·Anesthesiology
RC Screw-retained Abutment
FDA UDI
BIO CONCEPT Co., Ltd.·06947600303527·
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668103159·FUKASAKU LASIK SPATULA
PIPELINE
FDA UDI
Micro Therapeutics, Inc.·00847536008632·FA-71325-30 PIPELINE EMB DEVICE
Pipeline
FDA UDI
Micro Therapeutics, Inc.·00836462014787·Embolization Device
PIPELINE
FDA UDI
Micro Therapeutics, Inc.·00847536008618·FA-71325-30 PIPELINE EMB DEVICE
Aileron Posterior Fusion System
FDA UDI
Life Spine, Inc.·00190837000172·
Aileron Posterior Fusion System
FDA UDI
Life Spine, Inc.·00190837030469·AILERON Static Posterior Fusion Core, Short Bar...
Aileron Posterior Fusion System
FDA UDI
Life Spine, Inc.·00190837000165·
Aileron Posterior Fusion System
FDA UDI
Life Spine, Inc.·00190837030476·Core, Static Aileron, Medium Barrel, 10mm
Freedom Pedicle Screw System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215027339·
Aileron Posterior Fusion System
FDA UDI
Life Spine, Inc.·00190837030483·Core, Static Aileron, No Bullet, 10mm
Aileron Posterior Fusion System
FDA UDI
Life Spine, Inc.·00190837030490·Plate, Static Aileron, No Bullet, 10mm
3DI INCLUDING CSCORE
FDA 510(k)
FDA Class 2
·Radiology
MODIFICATION TO OMNILINK .035 BILIARY STENT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
IH 25° Anatomic Abutment
FDA UDI
SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD·07290120484481·
IH 25° Concave Curve Abutment
FDA UDI
SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD·07290120483538·
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 29, 2025
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 29, 2013
RESTORE ADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 1, 2014