15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil
FDA 510(k)
FDA Class 2
·Radiology
Empower Clear Bracket
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746200366·COSMETIC SL EMPOWER CLEAR INTERACT UL BIC 022 T...
Empower Clear
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746154843·COSMETIC SL EMPOWER CLEAR PASSIVE UL BIC 022 T-...
Empower Clear
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746000102·COSMETIC SL EMPOWER CLEAR PASSIVE UL BICUSPID 0...
Empower Clear Bracket
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746199813·COSMETIC SL EMPOWER CLEAR PASSIVE UL BIC 022 T-...
Empower Clear
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746154485·COSMETIC SL EMPOWER CLEAR INTERACT UL BIC 022 T...
Empower Clear
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746000843·COSMETIC SL EMPOWER CLEAR INTERACT UL BICUSPID ...
MULTI FUCTIONAL REHABILITATION CHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
Gastric Lightguide (GLG)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TENDER INFUSION SET
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS, INC.·Product code FPA·January 4, 2008
TEMA ELBOW SYSTEM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code JDB·September 26, 2024
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·November 5, 2008
AC POWER MODULE
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·July 15, 2011
ACCU-CHEK ® SPIRIT
FDA Adverse Event
Malfunction
·ROCHE HEALTH SOLUTIONS INC·Product code LZG·July 12, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025