12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MAM TWISTER
FDA 510(k)
FDA Class 2
·Dental
BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·December 18, 2019
MEDICAL CABLES PATIENT MONITORING CABLES FOR ECG, EEG, SPO2, AND BLOOD PRESSURE MONITORS
FDA 510(k)
FDA Class 2
·Cardiovascular
MIDAS TOUCH PURPLE NITRILE EXAMINATION GLOVES-POLYMER COATED, POWDER FREE
FDA 510(k)
FDA Class 1
·General Hospital
SYRINGE 1.0ML 30GA 8MM 7BAG 420CAS JP
FDA Adverse Event
Injury
·BD MEDICAL - DIABETES CARE·Product code FMF·June 28, 2019
SOLETRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·May 3, 2013
840 VENTILATOR
FDA Adverse Event
Injury
·COVIDIEN·Product code CBK·August 19, 2014
INTEGRITY RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MAF·May 10, 2011
BD ULTRA-FINE PEN NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·November 27, 2019
CAP FOR INJECTOR MEMBRANE M50
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·May 4, 2021
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
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024