13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
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
Child Deaver Blade
FDA UDI
KOROS U.S.A., INC.·10840199542939·Child Deaver Blade 3/4 x 3"
Arthrex®
FDA UDI
ARTHREX, INC.·10888867400624·Calibrated measurement wire 1.35. TiN
GYNECARE X-TRACT MORCELLATOR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code HET·June 8, 2006
BF-NAVI
FDA 510(k)
FDA Class 2
·Radiology
IMMUNO-WASH AUTOMATED TUBE WASHER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 8, 2013
ENDURANT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·February 11, 2011
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·August 8, 2014
XP-CR Tibial Tray - Interlok 71mm Item # 195273
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020