21 results · 26ms · Sources: EU EUDAMED, US FDA

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MODIFICATION TO ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

SchureMed

FDA UDI
SCHUERCH CORPORATION·00810014605388·MAQUET 1130 SPLIT LEG 4.25" DELUXE GEL

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450181720·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450182741·

SUPPORT SLEEVE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

HARDYDISK, CIPROFLOXACIN, 5MCG

FDA 510(k)
FDA Class 2 ·Microbiology

RD SET YI

FDA Adverse Event
Malfunction ·MASIMO - 52 DISCOVERY·Product code DQA·March 29, 2021

M-LNCS DC-I

FDA Adverse Event
Malfunction ·MASIMO - 40 PARKER·Product code DQA·November 21, 2016

M-LNCS DC-I

FDA Adverse Event
Malfunction ·MASIMO - 40 PARKER·Product code DQA·November 21, 2016

RADICAL-7

FDA Adverse Event
Malfunction ·MASIMO CORPORATION·Product code DQA·February 19, 2016

RAD-57 CONFIGURABLE PULSE CO-OXIMETER

FDA Adverse Event
Malfunction ·MASIMO - 40 PARKER·Product code DQA·June 24, 2019

DURATA STS OPTIM PASSIVE FIXATION, DF4 CONNECTOR

FDA Adverse Event
Death ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·April 26, 2013

SJM UNK

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 7, 2011

SOLETRA

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·July 22, 2008

RAINBOW RC-4

FDA Adverse Event
Malfunction ·MASIMO - 40 PARKER·Product code DQA·July 11, 2017

E-POLY TIBIAL BEARINGS

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code JWH·July 12, 2017

RD SET

FDA Adverse Event
Malfunction ·MASIMO - 15750 ALTON PKWY·Product code DQA·December 31, 2025

RD SET

FDA Adverse Event
Malfunction ·MASIMO - 15750 ALTON PKWY·Product code DQA·December 31, 2025

HANDLE CEV102910R DIA 10MM ANG W/RATCHET [MXI/XOM]

FDA Adverse Event
Injury ·XOMED MICROFRANCE MFG·Product code GCJ·December 20, 2013

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