7 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DENTURE RELINE MATERIAL
FDA 510(k)
FDA Class 2
·Dental
ML830TP
FDA 510(k)
FDA Class 2
·Physical Medicine
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff
FDA 510(k)
FDA Class 1
·General Hospital
TOTAL ASR ACET IMP SIZE 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD.-8010379·Product code KWA·April 30, 2014
PINNACLE MTL INS NEUT36IDX64OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code KWA·October 10, 2012
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·May 19, 2015
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c) 44, 47, 50, 53 head, Large, Item Number 314-02-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024