12 results · 25ms · Sources: EU EUDAMED, US FDA

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OEC 9900 ELITE

FDA 510(k)
FDA Class 2 ·Radiology

Bentson

FDA UDI
COOK INCORPORATED·00827002068056·Bentson Wire Guide 10cm Distal Flexibility with...

INRATIO2 PT/INR TEST STRIPS

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·May 3, 2016

MEDICAL CABLES PATIENT MONITORING CABLES FOR ECG, EEG, SPO2, AND BLOOD PRESSURE MONITORS

FDA 510(k)
FDA Class 2 ·Cardiovascular

MIDAS TOUCH PURPLE NITRILE EXAMINATION GLOVES-POLYMER COATED, POWDER FREE

FDA 510(k)
FDA Class 1 ·General Hospital

VANGUARD TIBIAL TRAY COMPONENT

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·August 20, 2018

VANGUARD FEMORAL COMPONENT

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·August 20, 2018

11MM/130 DEG TI CANN TROCH FIXATION NAIL 320MM/LEFT-STER

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code HSB·April 29, 2013

LIFEPAK 20 DEFIBRILLATOR/MONITOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC.·Product code LDD·July 24, 2008

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·May 3, 2011

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

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