11 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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