10 results · 22ms · Sources: EU EUDAMED, US FDA

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TRIFUSION, MODEL 0609190/0659350

FDA 510(k)
FDA Class 2 ·General Hospital

ULTRASIM CT SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

SIII ALARM AMPLIFIER

FDA 510(k)
FDA Class 2 ·Cardiovascular

ROI-C IMPLANT, UNKNOWN SIZE

FDA Adverse Event
Injury ·LDR MÉDICAL·Product code OVE·August 24, 2021

VITALITY 2

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 8, 2013

VERSA-FX STANDARD REAMER HEAD

FDA Adverse Event
Injury ·ZIMMER INC·Product code HTO·March 29, 2011

CAPSUREFIX NOVUS

FDA Adverse Event
Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·May 12, 2008

SPACER, UNKNOWN SIZE

FDA Adverse Event
Injury ·LDR MEDICAL·Product code ODP·August 23, 2019

ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494

FDA Enforcement
Class II ·Ongoing·Smith & Nephew, Inc.·October 28, 2020

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