12 results · 21ms · Sources: EU EUDAMED, US FDA

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ENVOY GUIDING CATHETERS

FDA 510(k)
FDA Class 2 ·Cardiovascular

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450426296·

RS BIOTECH GALAXY 'R' CO2 INCUBATOR

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

ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

ACL TOP

FDA Adverse Event
INSTRUMENTATION LABORATORY CO.·Product code GKP·May 13, 2005

ACL TOP

FDA Adverse Event
Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code GKP·July 21, 2005

ACL ADVANCE

FDA Adverse Event
INSTRUMENTATION LABORATORY CO.·Product code JPA·April 22, 2005

VET DCP 3.5 8HO L97 SST

FDA Adverse Event
Malfunction ·SYNTHES ELMIRA·Product code HRS·May 4, 2013

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·September 16, 2014

TERUMO PERFUSION SYSTEM 8000

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code JOR·May 3, 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