9 results · 36ms · Sources: EU EUDAMED, US FDA

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RADLITE TISSUE RETRACTOR SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

PROCLUDE

FDA 510(k)
FDA Class 1 ·Dental

DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070

FDA 510(k)
FDA Class 2 ·Cardiovascular

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·January 25, 2024

PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·March 21, 2013

TERUMO CDI 500 BLOOD PARAMETER MONITOR

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·February 24, 2011

GALILEO

FDA Adverse Event
Malfunction ·IMMUCOR, INC.·Product code KSZ·April 3, 2008

BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM

FDA Adverse Event
Malfunction ·BD SUZHOU (MDS)·Product code FOZ·August 23, 2024

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