10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK
FDA 510(k)
FDA Class 2
·Neurology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450210550·
35C50EA Ultrasonic Transducer(FDA)
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904089386·
CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY
FDA 510(k)
FDA Class 2
·Hematology
DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
FDA 510(k)
FDA Class 1
·General Hospital
3M TEGADERM ALGINATE AG SILVER DRESSING
FDA Adverse Event
Injury
·3M HEALTH CARE·Product code FRO·June 21, 2016
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 2, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 15, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·May 3, 2011
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