16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Prontosan Wound Gel
FDA 510(k)
FDA Unclassified
·Unknown
Best Medical International
FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365118029·
Best Medical International
FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365115653·
PROULTRA PIEZO ULTRASONIC
FDA 510(k)
FDA Class 2
·Dental
ZERO PROFILE ANTERIOR CERVICAL PLATE (ACP) SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BERLIN HEART EXCOR
FDA Adverse Event
Injury
·BERLIN HEART·Product code DSQ·June 11, 2013
UNKNOWN DEPUY 2.5 CVD 10MM INSERT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·June 24, 2011
ACCU-CHEK ULTRAFEX INFUSION SET
FDA Adverse Event
Malfunction
·DISETRONIC MEDICAL SYSTEMS·Product code FPA·September 10, 2008
CONTOUR® PLUS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·February 20, 2025
FLEXOR SHUTTLE TIBIAL GUIDING SHEATH
FDA Adverse Event
Injury
·COOK INC·Product code DYB·October 29, 2025
FLEXOR SHUTTLE TIBIAL GUIDING SHEATH
FDA Adverse Event
Injury
·COOK INC·Product code DYB·October 29, 2025
DYB INTRODUCER, CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code DYB·November 12, 2025
FLEXOR SHUTTLE SELECT GUIDING SHEATH
FDA Adverse Event
Injury
·COOK INC·Product code DYB·October 29, 2025
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·September 15, 2020
FLEXOR SHUTTLE SELECT GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·February 7, 2020
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