9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System
FDA 510(k)
FDA Class 2
·Orthopedic
LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743
FDA 510(k)
FDA Class 2
·Hematology
MICROTABLE SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
BD VACUTAINER¿ VENOUS BLOOD COLLECTION TUBES: SST¿ W/ GOLD HEMOGARD
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·November 30, 2017
HEARTSTART MRX - EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 11, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·August 25, 2011
ACCU-CHEK ® FASTCLIX LANCETS
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code FMK·July 18, 2013
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025