8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE
FDA 510(k)
FDA Class 2
·Physical Medicine
KENDRO HERACELL 240 INCUBATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT
FDA 510(k)
FDA Class 2
·Hematology
SPACEMAKER BLUNT TIP TROCAR 10MM
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY USSC PUERTO RICO, INC.·Product code GCJ·March 28, 2013
SPRING WIRE GUIDE COMPONENT
FDA Adverse Event
Injury
·ARROW INTL., INC.·Product code DQX·June 20, 2008
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON·Product code FTL·April 19, 2011
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