28 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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COMPUMEDICS E-SERIES EEG SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
Bio2 Technologies
FDA UDI
BIO2 TECHNOLOGIES, INC.·B01010000681·VITRIUM C
SMALL, 7 x 16
QB1 NMES System
FDA UDI
Motive Health, Inc.·00854816006424·QB1 Post-Op Brace, NMES System; 3X-LARGE, REGUL...
OC-Auto
FDA UDI
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC·00816917022383·Personal Use Kit OC-Auto, for Iron Mountain, MI
OC-Auto
FDA UDI
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC·00816917026220·OC-Auto SENSOR io Personal Use Kit for VA Iron ...
Matrix Holter System
FDA UDI
GLOBAL INSTRUMENTATION, LLC·90815187020399·M12A Enterprise System Software
Panama™
FDA UDI
FLOSPINE LLC·B1830840000680·4-Level, 68mm Cervical Plate
TRABECULAR METAL™
FDA UDI
ZIMMER TRABECULAR METAL TECHNOLOGY INC.·00889024310933·
PERSONA®
FDA UDI
Zimmer, Inc.·00889024228818·
PERSONA®
FDA UDI
Zimmer, Inc.·00889024228825·
RENAFLO II HF 2000 HEMOFILTER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BRANEMARK NOVUM
FDA 510(k)
FDA Class 2
·Dental
PERSONA ARTICULAR SURFACE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code MBH·May 5, 2016
HUDSON OPTI-NEB PRO COMPRESSOR W/DISP NEB.
FDA Adverse Event
Malfunction
·TELEFLEX·Product code CAF·March 8, 2013
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·February 3, 2011
FREESTYLE
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE INC, USA·Product code LFR·February 15, 2008
PERSONA CEMENTED STEMMED TIBIAL PLATE
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code JWH·October 31, 2016
PERSONA CEMENTED POSTERIOR FEMORAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER ORTHOPAEDIC MFG. LTD.·Product code JWH·October 31, 2016
UNFOLDER PLATINUM 1 SERIES
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code KYB·January 8, 2025
UNFOLDER PLATINUM 1 SERIES
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code KYB·January 8, 2025