10 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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The Nanostim Introducer Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
B-P TOTAL HIP SYSTEM
FDA UDI
ENDOTEC, INC.·00814193024596·B-P MODULAR EXTENSION W/ULTRACOAT - 16 MM X 175 MM
AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5
FDA 510(k)
FDA Class 2
·Hematology
VERSA-DIAL HUMERAL HEAD PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
UNKNOWN NOTTINGHAM SHOULDER
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code MBF·May 17, 2017
COMPREHENSIVE SHOULDER SYSTEM MODULAR HEAD - VARIABLE OFFSET 42MM X 18MM X 46MM
FDA Adverse Event
Malfunction
·BIOMET ORTHOPEDICS·Product code HSD·October 19, 2016
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 10, 2013
GOBED II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·June 30, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·September 5, 2008
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018