13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CRANK FRAME RETRACTOR
FDA 510(k)
FDA Class 2
·Neurology
TRUELOK EVO
FDA UDI
ORTHOFIX SRL·18052469471920·TRUELOK EVO RX 3/8 MODULAR RING D160MM STERILE
AVITA RADAR THERMO IR THERMOMETER, NT1 SERIES
FDA 510(k)
FDA Class 2
·General Hospital
VENTILATOR, MINILUNG
FDA 510(k)
FDA Class 2
·Anesthesiology
40MM ÿ +6MM OFFSET 65º NECK ANGLE RETENTIVE POLY LINER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·April 20, 2023
GLENOSPHERE +3 MM LATERAL OFFSET 40 MM DIAMETER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·April 20, 2023
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 18, 2014
PELVISOFT ACELLULAR COLLAGEN BIOMESH
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTM·December 14, 2012
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·October 1, 2010
36MM ÿ +6MM OFFSET 65º NECK ANGLE RETENTIVE POLY LINER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·March 23, 2023
COMP RVSR SHLDR GLNSP +3 36MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·March 23, 2023
18MM ÿ 130MM LENGTH HUMERAL STEM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·March 23, 2023
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020