14 results
·
21ms
·
Sources: EU EUDAMED, US FDA
WOUND DRAINAGE HOLDER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
artegral HD
FDA UDI
Merz Dental GmbH·D7091973183·posteriors; shade BL3; size L; lower jaw
TDXR MULTICONSTIT. CONTROLS FOR ABUSED DRUG ASSAYS
FDA 510(k)
FDA Class 1
·Clinical Toxicology
CEDIA Heroin Metabolite (6-AM) Assay
FDA 510(k)
FDA Class 2
·Clinical Toxicology
BD FACSCALIBUR¿ FLOW CYTOMETER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·January 31, 2023
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
KENSTONE METAL·Product code IKX·February 21, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·August 1, 2014
MINI-CAP WITH POVIDONE LODINE
FDA Adverse Event
Malfunction
·Product code KDI·January 28, 2011
BD FACSCALIBUR FLOW CYTOMETER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·March 31, 2023
BD FACSCALIBUR¿ FLOW CYTOMETER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·March 31, 2023
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORP.·Product code NIQ·December 21, 2006
BD FACSCALIBUR¿ FLOW CYTOMETER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·January 20, 2023
BD FACSCALIBUR¿ FLOW CYTOMETER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 24, 2023
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