14 results · 21ms · Sources: EU EUDAMED, US FDA

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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