15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CALCIUM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CALCIUM
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES (IRVING IA/CC)·Product code CJY·September 1, 2020
LIQUISPX LIQUID LIPID CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EEA 28MM SINGLE-USE STAPLER
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY USSC PUERTO RICO INC·Product code GDW·June 1, 2015
EEA31
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY USSC PUERTO RICO INC·Product code GDW·August 31, 2015
PREMIUM PLUS CEEA* 28 INSTR. W/TILT-TOP*
FDA Adverse Event
Injury
·COVIDIEN MEDICAL PRODUCTS (SHANGHAI) MAN·Product code GDW·November 4, 2015
COBAS INTEGRA 800
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·April 17, 2013
IMMULITE 2500 OMMA (CA125)
FDA Adverse Event
Other
·SIEMENS HEALTHCARE DIAGNOSTICS LTD.·Product code LTK·June 18, 2008
DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code KNT·April 19, 2011
DST SERIES ORVIL AUTOMATIC 25MM DEVICE
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GDW·April 25, 2016
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 12, 2022
EEA 31MM SINGLE-USE STAPLER
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY USSC PUERTO RICO INC·Product code GAG·December 11, 2015
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