28 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BluEX Lumbar Expandable Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
DBX STRIP
FDA 510(k)
FDA Class 2
·Orthopedic
Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer, Ansel Modification; Flexor Check-Flo Introducers, Ansel Modification with High-Flex Dilator and Hydrophilic Coating; Flexor Check-Flo Introducer Balkin Up and Over Contralateral Design; Flexor Up and Over Balkin Contralateral Introducer; Flexor Check-Flo Introducer, Raabe Modification; Flexor Check-Flo Performer Introducer
FDA 510(k)
FDA Class 2
·Cardiovascular
FLEXOR RTPS GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·February 27, 2020
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 11, 2014
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 23, 2013
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·March 12, 2015
FLEXOR SHUTTLE TIBIAL GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·September 29, 2020
ARCOS 17X150MM SPL TPR DIST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·June 12, 2024
ARCOS CON SZ C STD 60MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·June 12, 2024
FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·March 3, 2020
THAL-QUICK CHEST TUBE SET
FDA Adverse Event
Malfunction
·COOK INC·Product code GBX·January 7, 2020
FLEXOR ANSEL GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·March 3, 2020
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·January 10, 2022
FLEXOR ANSEL GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·October 22, 2019
FLEXOR RAABE GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·December 11, 2019
FLEXOR ANSEL GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·October 22, 2019
FLEXOR RAABE GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·November 27, 2019
FLEXOR ANSEL GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·November 18, 2019