17 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ONE PERSONAL LUBRICANT (WATER BASED)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LumenCare Azure
FDA UDI
Nucletron B.V.·08717213025530·LumenCare Azure, 5F x 140cm Set for Flexitron
LumenCare Azure
FDA UDI
Nucletron B.V.·08717213056770·LumenCare Azure Set 5F, 140cm
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383504089·Gutta Percha Points is used to root canal filin...
BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION
FDA 510(k)
FDA Class 2
·Radiology
OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500
FDA 510(k)
FDA Class 2
·Radiology
MERSILENE TAPE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code KDC·November 20, 2018
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
LAMITRODE S8
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 10, 2013
MEDISENSE OPTIUM
FDA Adverse Event
Malfunction
·Product code NBW·June 1, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 14, 2008
BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·September 25, 2023
MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
FDA Enforcement
Class II
·Terminated·Ecolab Inc·February 19, 2014
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021