13 results · 20ms · Sources: EU EUDAMED, US FDA

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SCD THERAPEUTIC STOCKING SYSTEM

FDA 510(k)
FDA Class 2 ·General Hospital

SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM, VERSION 1.1

FDA 510(k)
FDA Class 2 ·Neurology

MODEL 4810 ANALYZER OUTPUT ADAPTER

FDA 510(k)
FDA Class 2 ·Cardiovascular

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX #3/11 MM R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 31, 2023

OCTRODE LEAD KIT, 60CM LENGTH

FDA Adverse Event
Injury ·ABBOTT MEDICAL·Product code LGW·March 22, 2023

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/13 MM R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 4, 2019

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 12, 2025

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/13 MM R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 16, 2020

TRILOGY 100

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code CBK·May 7, 2014

MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES, INC·Product code LWR·November 11, 2010

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code ITI·January 8, 2013

UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260

FDA Enforcement
Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

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