11 results · 27ms · Sources: EU EUDAMED, US FDA

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STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK

FDA 510(k)
FDA Class 2 ·Immunology

3D ENDOSCOPE

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

DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER

FDA 510(k)
FDA Class 2 ·Anesthesiology

A7 ANESTHESIA SYSTEM

FDA Adverse Event
Malfunction ·SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.·Product code BSZ·February 15, 2017

ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·February 12, 2025

SWARTZ BRAIDED INTRODUCER, 8.5F, SL1

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, INC. (AF-MINNETONKA)·Product code DYB·April 12, 2013

HICKMAN 7 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCER

FDA Adverse Event
Malfunction ·C. R. BARD INC., (BASD)·Product code LJS·March 21, 2011

ANGIO-SEAL DEVICE

FDA Adverse Event
Injury ·ST. JUDE MEDICAL·Product code MGB·June 11, 2008

COAGUCHEK XS SYSTEM

FDA Adverse Event
Injury ·ROCHE DIAGNOSTICS·Product code GJS·August 10, 2020

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

CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015