10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Guardian Angel GA1000 Digital Vital Sign Monitoring System
FDA 510(k)
FDA Class 2
·Cardiovascular
BOWMAN LACRIMAL PROBE
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896018624·BOWMAN LACRIMAL PROBE SIZE 7-8 BUTTERFLY HANDLE...
BI-METRIC HEAD/NECK HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304223042·
VANGUARD REMOVABLE MOLDED POLY TIBIA
FDA 510(k)
FDA Class 2
·Orthopedic
GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784)
FDA 510(k)
FDA Class 2
·Neurology
BD VACUTAINER® URINE COLLECTION CUP
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·December 5, 2019
DRILL BIT Ø2/1.15 CANN L150/48 3FLUTE
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HWE·June 11, 2013
CONTAK RENEWAL
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 14, 2011
FRESENIUS 2008K
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·October 7, 2014
RECLAIM DISTAL TAPERED Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014