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