18 results
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24ms
·
Sources: EU EUDAMED, US FDA
GALILEO Spine Alignment Monitoring System
FDA 510(k)
FDA Class 2
·Neurology
PROPELLER HEAD SCREW SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304270282·
MiniSPC Button
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071148164·18F x 2.5cm MiniSPC Low Profile Suprapubic Cath...
MiniSPC Button
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071150785·18F x 2.5cm MiniSPC Low Profile Suprapubic Cath...
BD RODAC¿ SNAP LID TRYPTICASE¿ SOY AGAR (TSA) W LECITHIN & POLYSORBATE 80
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·December 7, 2022
MINI GHOST, MODEL: 507
FDA 510(k)
FDA Class 2
·Cardiovascular
FUTURA
FDA 510(k)
FDA Class 2
·Physical Medicine
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 19, 2011
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 14, 2013
*
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·July 21, 2008
VANGUARD ROCC POR FEM S60 L
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code JWH·February 3, 2026
ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET
FDA Adverse Event
Injury
·COOK INC·Product code FGE·April 25, 2019
ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET
FDA Adverse Event
Injury
·COOK INC·Product code FGE·January 4, 2019
ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET
FDA Adverse Event
Injury
·COOK INC·Product code FGE·February 18, 2019
ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FGE·July 26, 2019
VANGUARD MONO FINNED STM TIB 71X8
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code JWH·August 9, 2023
VANGUARD ROCC POR FEM S60 L
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code JWH·February 20, 2025
Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001
FDA Enforcement
Class II
·Ongoing·Cook Vandergrift, Inc.·September 13, 2023