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

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NUVASIVE HELIX REVOLUTION ACP SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

LEONE SPA

FDA UDI
LEONE SPA·08033707065708·INTRAORAL ELASTICS 4,5 oz 1/4" red

SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801

FDA 510(k)
FDA Class 2 ·Cardiovascular

SOCRATES ROBOTIC TELEMONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MEDACTA KNEE IMPLANTS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 28, 2016

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 21, 2025

ACRYSOF

FDA Adverse Event
Injury ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·April 30, 2013

X3 TRIATHLON CS INSERT #6 11MM

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code MBH·September 16, 2014

FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code GEX·May 18, 2011

LIFEPAK 12 defibrillator/monitor.

FDA Recall
Terminated ·Medtronic Physio Control Corp·Product code LDD·April 5, 2004

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