15 results · 22ms · Sources: EU EUDAMED, 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