28 results · 23ms · Sources: EU EUDAMED, US FDA

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ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A)

FDA 510(k)
FDA Class 2 ·Ophthalmic

B.BRAUN

FDA UDI
B.Braun Avitum AG·04046964249679·EMPTY BAGS FOR DIALYSATE FUTURA (US)

Ormco

FDA UDI
ORMCO CORPORATION·00889989031201·SPRING COIL SPACE WOUND PKG 009 X 030

LIFT VB SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

ACTIVE WASTE GAS SCAVENGER

FDA 510(k)
FDA Class 2 ·Anesthesiology

SHARPS COLL WALLMATE 5.4QT BEIGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMI·January 15, 2020

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 22, 2024

BD SYRINGE LUER-LOK TIP

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·March 25, 2020

130° RADIOLUCENT TARGETING ARM

FDA Adverse Event
Malfunction ·ARTHREX, INC.·Product code HSB·January 13, 2025

CUSA EXCEL 36KHZ CURVED EXTENDED MICRO

FDA Adverse Event
Malfunction ·INTEGRA LIFESCIENCES(IRELAND)·Product code LFL·March 20, 2019

(01)00844868029717(17)210930(10)2016091064

FDA Adverse Event
Injury ·BIOMET 3I·Product code DZE·July 10, 2023

INFUSION SET

FDA Adverse Event
Injury ·ALARIS·Product code FPA·October 23, 2008

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MGB·August 12, 2011

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 8, 2013

Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK, REF C74339 Access SARS-CoV-2 IgG (1st IS) Calibrators, REF C74340 Access SARS-CoV-2 (1st IS) Quality Control (QC), REF C74341

FDA Enforcement
Class II ·Terminated·Beckman Coulter Inc.·September 29, 2021

POWERPICC SV CATHETER 4F BASIC TRAY

FDA Adverse Event
Malfunction ·C.R. BARD, INC. (BASD) -3006260740·Product code LJS·March 19, 2021

CareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use Only, Rx only, Catalog Number PIG1280T, UDI Number 01)10885403108402(17) 210930(10)0001304986

FDA Recall
Terminated ·Becton Dickinson & Company·Product code GCB·March 26, 2020

CareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use Only, Rx only, Catalog Number PIG1280T, UDI Number 01)10885403108402(17) 210930(10)0001304986

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Company·May 6, 2020

CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and Marking. For use in the treatment of hydrocephalus. Catalog Number: NS5524

FDA Enforcement
Class II ·Terminated·Integra LifeSciences Corp.·April 14, 2021

Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK

FDA Enforcement
Class II ·Ongoing·Beckman Coulter Inc.·October 13, 2021