11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x 135cm, FLASH Mini Ostial System - 4.0mm x 8mm x 135cm, FLASH Mini Ostial System - 4.5mm x 8mm x 135cm
FDA 510(k)
FDA Class 2
·Cardiovascular
SHERLOCK MICROBIAL IDENTIFICATION SYSTEM FOR BIODEF
FDA 510(k)
FDA Class 2
·Microbiology
RE-TRACE URETERAL ACCESS SHEATH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·RICE CREEK MFG·Product code LWP·June 7, 2013
S-ICD SYSTEM
FDA Adverse Event
Injury
·CAMERON HEALTH INC.·Product code NVY·July 14, 2014
NDEHP MICRO 7IN EXT
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code FPK·June 27, 2011
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·November 28, 2017
MONOCRYL PLUS ANTIBACTERIAL SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·November 28, 2017
MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAN·November 28, 2017
VICRYL PLUS POLYGLACTIN 910 SUTURE UNKNOWN PROD
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·November 28, 2017
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023