10 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option
FDA 510(k)
FDA Class 2
·Anesthesiology
Cosmolock
FDA UDI
Kalitec Direct LLC·B07310K1190130·Tray Insert 5, Cosmo MIS,Arcamed
DRILL, AO, STERILE 4, 2X340 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·September 23, 2011
MODIFICATION TO SCINTRON IV
FDA 510(k)
FDA Class 2
·Radiology
SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND
FDA 510(k)
FDA Unclassified
·Unknown
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
MEDTRONIC MINIMED·Product code OYC·October 21, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·June 21, 2013
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·July 19, 2011
dS Breast 7ch 3.0T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024
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