14 results
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21ms
·
Sources: EU EUDAMED, US FDA
Perfect-O Ostial Positioning Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613018023·K-Wire, Single Ended, Trocar Point, Diameter Si...
BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·December 17, 2019
MasterLoc Stem
FDA 510(k)
FDA Class 2
·Orthopedic
EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·February 14, 2020
BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 20, 2024
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·November 18, 2014
PULSE GEN MODEL UNKNOWN
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·September 1, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·August 1, 2013
BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·March 4, 2020
TRUE METRIX AIR
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·December 31, 2020
CUP: MPACT ACETABULAR SHELL Ø50 TWO-HOLES
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·January 26, 2022
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012