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

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CODMAN HAKIM MICRO II VALVE

FDA 510(k)
FDA Class 2 ·Neurology

LEONE SPA

FDA UDI
LEONE SPA·08033707065753·INTRAORAL ELASTICS 6,5 oz 5/16" blue

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450218433·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450462461·

WAVEWRITER ALPHA

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 31, 2023

ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX

FDA 510(k)
FDA Class 2 ·Cardiovascular

READYSWIM

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 17, 2025

LUX 1440

FDA Adverse Event
Malfunction ·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012

IDENTITY ADX XL DR

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·January 14, 2014

ANESTAR ANESTHESIA SYSTEM

FDA Adverse Event
Malfunction ·MINDRAY DS USA, INC.·Product code BSZ·April 30, 2013

X-SMART

FDA Adverse Event
Malfunction ·DENTSPLY MAILLEFER·Product code LQY·May 5, 2011

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