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