9 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PFT FILTER
FDA 510(k)
FDA Class 2
·Anesthesiology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123199·K-WIRE - SINGLE TROCAR THREADED 2.0mm DIA x 150mm
iNSitu™ Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127023897·Short Modular Drill Bit
BIOFOAM Bone Wedge
FDA 510(k)
FDA Class 2
·Orthopedic
ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES
FDA 510(k)
FDA Class 2
·Orthopedic
ELECTRODE, PACEMAKER, PERMANENT
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·February 9, 2013
STENOSCOP
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD·Product code JAA·January 4, 2011
OMNIPOD INSULIN PUMP
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·July 17, 2014
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024