8 results
·
21ms
·
Sources: EU EUDAMED, US FDA
RX ROCKER TRIUMPH WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
CANON DIGITAL FLUOROSCOPY AND RADIOGRAPHY, MODEL CXDI-50RF
FDA 510(k)
FDA Class 2
·Radiology
FUNNEL GUIDE CATHETER MODEL G1020608
FDA 510(k)
FDA Class 2
·Cardiovascular
FLEXI-SEAL CONTROL FMS KIT US
FDA Adverse Event
Malfunction
·CONVATEC INC.·Product code KNT·May 7, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·January 8, 2013
X-STOP IPD SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SPINE LLC.·Product code NQO·October 22, 2010
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
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