14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FRONTIER MODEL X5
FDA 510(k)
FDA Class 2
·Physical Medicine
Hawkin Ambler Dilator
FDA UDI
MEDGYN PRODUCTS, INC.·M803030783·Hawkin Ambler Dilator 5-8 mm
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120307831·Diamond, cylinder round, medium grit
Iconix
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746146107·1 PAT SETUP COSMETIC ICONIX MMS ROTH 022 U/L 5...
IBP_CO_MicrostreamCO2 module(FDA/FJ/PK.)
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904086118·
DIRECT TIBC CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MEDICAL DEPOT-WHEELCHAIRS, MODEL SENTRA,ASTAIRE AND VIPER
FDA 510(k)
FDA Class 1
·Physical Medicine
3 ML BD LUER-LOK¿ SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 5, 2017
LIFEPAK CR(R) PLUS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·April 2, 2013
3.5FR P.U.R. UMBIL CATH X10
FDA Adverse Event
Malfunction
·COVIDIEN·Product code FOS·March 22, 2011
CARTO XP EP NAVIGATION SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER LTD. (HAIFA, ISREAL)·Product code DQK·April 17, 2008
Universal Nerve Block Tray Catalog Number: 9818
FDA Enforcement
Class II
·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024