28 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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