10 results · 19ms · Sources: EU EUDAMED, US FDA

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Nexo-Gide Bilayer Collagen Membrane

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·October 8, 2020

CANNULATED SCREW SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Aer X

FDA 510(k)
FDA Class 2 ·Anesthesiology

BD PARADIGM LINK GLUCOSE MONITOR

FDA Adverse Event
Malfunction ·NOVA BIOMEDICAL CORP·Product code NBW·October 17, 2008

CAPSUREFIX

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

TOTAL ASR ACET IMP SIZE 56

FDA Adverse Event
Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·July 2, 2013

EMBLEM MRI S-ICD Model A219

FDA Enforcement
Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

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

EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021