10 results · 18ms · Sources: EU EUDAMED, US FDA

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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