10 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BARD UROFORCE BALLOON DILATION CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GIANT LUMEN SAFETIP SERIES: ENDOMYOCARDIAL BIOPSY
FDA 510(k)
FDA Class 2
·Cardiovascular
MICROTAK PLUS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
EARIGATOR
FDA Adverse Event
Malfunction
·SURYA TECHNOLOGIES INTERNATIONAL·Product code JYH·January 4, 2001
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·February 19, 2016
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code KWP·April 9, 2015
OSCILL-SAW-ATTACHM F/532.001 532.010 532
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·March 8, 2013
UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JGS·February 16, 2011
TRANSVENOUS LEAD
FDA Adverse Event
Injury
·MPRI·Product code DTB·August 8, 2014
BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020