8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Zaga Zygomatic System
FDA 510(k)
FDA Class 2
·Dental
ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 14MM ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 16MM
FDA 510(k)
FDA Class 2
·Orthopedic
Aulisa Multiple Patient Digital Vital Sign Monitoring System
FDA 510(k)
FDA Class 2
·Cardiovascular
PEDICLE SCREW MUST MC SCREW Ø5.5X45 CANNULATED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·June 14, 2024
HYLAMER 10D 54OD X 28ID
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HRY·November 5, 2008
RENAISSANCE 26 STRETCHER
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·July 13, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 12, 2013
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014