9 results
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26ms
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Sources: EU EUDAMED, US FDA
DRAEGER ALCOTEST 6510
FDA 510(k)
FDA Class 1
·Clinical Toxicology
SUCTION IRRIGATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
POWDERED LATEX MEDICAL MEDICAL EXAMINATION GLOVES WITH 150 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER DM2
FDA 510(k)
FDA Class 1
·General Hospital
X3 TRIATHLON CS INSERT #3 9MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·May 13, 2014
OUTLOOK ES
FDA Adverse Event
Malfunction
·B. BRAUN MEDICAL, INC.·Product code FRN·April 12, 2013
PERMACOL PRODUCT
FDA Adverse Event
Malfunction
·COVIDIEN, FORMELRY TISSUE·Product code FTL·July 8, 2014
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·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