14 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DOLPHIN 2000 OXIMETRY SENSORS, MODELS 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342, 2343, 2344, 2220, 2260 AND 2422
FDA 510(k)
FDA Class 2
·Cardiovascular
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033876·Baltic Denture System BDLoad BDLoad Sm7 PLSEbm...
BD VENFLON¿ IV CATHETERS
FDA Adverse Event
Injury
·BECTON DICKINSON·Product code FOZ·December 1, 2021
INFRARED EAR THERMOMETER, MODEL DX-707
FDA 510(k)
FDA Class 2
·General Hospital
US SENSOR #CG-930P; TOCO SENSOR CG-940P
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MED SYSTEMS ELECTRO FLO 5000 PERCUSSOR, 30 POWER/FREQUENCY SETTINGS AN
FDA Adverse Event
Injury
·MED SYSTEM, INC.·Product code BYI·September 21, 2018
TECNIS
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code MFK·April 3, 2013
UNICEL® DXL 800 ACCESS® IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·March 30, 2011
PUMP MMT-722NAS PRDGM INS V2.2 SK EN
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·April 24, 2008
30 ML BD¿ BULK SLIP TIP SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·March 2, 2018
Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in a clinical treatment environment. Used for infusion of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions, and other therapeutic fluids.
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·November 30, 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
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013