7 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MYOMA DRILL 5MM-8383.611
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC
FDA 510(k)
FDA Class 2
·Orthopedic
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·December 17, 2010
CRUTCH
FDA Adverse Event
UNKNOWN·Product code IPR·February 4, 2013
OMNIPOD INSULIN PUMP
FDA Adverse Event
Injury
·INSULET CORP·Product code LZG·July 7, 2014
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024