8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
EG-3670URK
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NBS CONNECTING TUBE SET
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L
FDA 510(k)
FDA Class 2
·Immunology
11.0MM TI HELICAL BLADE 95MM
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code HSB·April 16, 2013
VITROS 5,1 FS CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·April 18, 2011
ACCU-CHEK AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS CORP.·Product code LFR·June 13, 2008
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