9 results
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19ms
·
Sources: EU EUDAMED, US FDA
SAGICO Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
ECHO SOUNDER, ES-102EX
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Hemoclip
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RIATA ACTIVE FIXATION LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008
EPIC II CRITICAL CARE BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·August 16, 2011
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·July 12, 2013
BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER WITH WINGS
FDA Adverse Event
Injury
·Product code FOZ·July 28, 2021
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018