12 results
·
28ms
·
Sources: EU EUDAMED, US FDA
CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EVOLUT FX PLUS VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 6, 2025
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·10304040115678·Roth Brackets .018" UL1 12T 5A 0O
INSTANT-VIEW BARBITURATE URINE CASSETTE TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
REVOLUTION FORMULA 2
FDA 510(k)
FDA Class 2
·Dental
SEXTANT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·October 1, 2010
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 17, 2013
COBAS 6000 C501 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CEM·June 19, 2008
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code FPA·April 19, 2011
FUSION QUATTRO EXTRACTION BALLOON
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code GCA·May 20, 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
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