8 results
·
21ms
·
Sources: EU EUDAMED, US FDA
EXPRESSWAY INTERMITTENT CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
6F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722; 6F EAVUATOR ELECTROPHYSISOLOGY CATHETER, JSN #402721, 4027
FDA 510(k)
FDA Class 2
·Cardiovascular
OLYMPUS XGIF-N200H GASTROINTESTINAL VIDEOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PRECISION SPECTRA®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 4, 2014
COULTER® LH 750 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code GKZ·April 18, 2011
RADIFOCUS GLIDEWIRE
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·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