10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
JOINT MOTON IMAGER(TM)
FDA 510(k)
FDA Class 2
·Radiology
TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SOPROLIFE
FDA 510(k)
FDA Class 2
·Dental
ATLAS PLUS DR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·January 8, 2013
DEXTRUS 4135
FDA Adverse Event
Injury
·BIOTRONIK SE & CO, KG·Product code NVZ·November 12, 2010
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·May 9, 2014
IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4
FDA Adverse Event
Injury
·MEDTRONIC XOMED INC.·Product code ERL·February 13, 2017
Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·November 12, 2025
DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
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