9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires
FDA 510(k)
FDA Class 2
·Cardiovascular
sentida sc-xl USA
FDA UDI
WISSNER-BOSSERHOFF GmbH·04050621100609·
CHORD-X EPTFE SUTURE
FDA 510(k)
FDA Class 2
·Cardiovascular
FIA Blood Glucose Monitoring System (G2)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 19, 2011
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 26, 2013
ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER
FDA Adverse Event
Malfunction
·MINNTECH COR·Product code FEB·September 26, 2008
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
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