11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SM IMPLANT SYSTEMS
FDA 510(k)
FDA Class 2
·Dental
BD SYRINGE 10ML LL S/C 200
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·June 13, 2024
BIOZTECT SENSOR AND BIOZTECT CABLE
FDA 510(k)
FDA Class 2
·Cardiovascular
L.E.DEMETRON
FDA 510(k)
FDA Class 2
·Dental
STICK SPONGE PVP PAINT
FDA Adverse Event
Malfunction
·COVIDIEN·Product code KXF·March 29, 2013
INTERSTIM
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·March 30, 2011
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·June 13, 2008
BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·July 10, 2018
BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·September 13, 2018
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