15 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ATLANTIS ABUTMENT IN ZIRCONIA FOR BIOHORIZONS IMPLANT
FDA 510(k)
FDA Class 2
·Dental
CADD
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·July 10, 2020
EBI XFIX ACCESS PELVIC FIXATOR
FDA 510(k)
FDA Class 2
·Orthopedic
(DISPOSABLE) VAGINAL SPECULUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
VERCISE GEVIA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code MHY·December 20, 2021
ADVIA CENTAUR XP
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·April 23, 2013
ALTRUA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·May 2, 2011
RIATA ST OPTIM ACTIVE-FIXATION LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008
VERCISE CARTESIA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·November 24, 2020
PINNACLE SECTOR II CUP 60MM
FDA Adverse Event
Injury
·. DEPUY ORTHOPAEDIC INC, 1818910·Product code KWA·May 25, 2018
979195 Loaner Kit for femoral intramedullary nail. Orthopedic instrument.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 7, 2018
14-442000S Antegrade Femoral Nail Instrument Kit, orthopedic instrument
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 7, 2018
Phoenix Antegrade Femoral Nail Trochanteric and Piriformis fossa, Model#14-442093 Antegrade Femoral Connecting Bolt. orthopedic instrument
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 7, 2018
Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and fixation of fractures. 3.5mm Inserter Connector, Short; Model Number: 14-441045; Kit Model Numbers: 14-400082, 14-400082S, 14-440065S, 14-442000-00, 14-442000S, 14-444000-00, 979105, 14-441045-00, and 14-444000S
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·April 4, 2018
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012