13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable
FDA 510(k)
FDA Class 2
·Cardiovascular
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH
FDA 510(k)
FDA Class 2
·General Hospital
MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Neurology
DELTA CER HEAD 11/13 36MM +3
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LZO·April 26, 2023
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 25, 2024
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·June 20, 2013
SYNCHRON LX I 725
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code CGA·July 1, 2011
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 10, 2014
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·February 26, 2020
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