16 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Navigator (FMNVG15); Navigator XL (FMNVX06)
FDA 510(k)
FDA Class 2
·Physical Medicine
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776182007·Bruns Curette hollow hdl str oval
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780455431·Integra® Jarit® Bruns Oval Cup Curette, Straigh...
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481125270·LOCATOR R-Tx Attachment System, 3.5mm, Performa...
Holder, Needle, TC, Automatic 15.5cm flat jaw
FDA UDI
Geister Medizintechnik GmbH·04057034064115·Holder, Needle, TC, Automatic
15.5cm...
Ballard* Multi-Access Port Closed Suction System
FDA UDI
Avanos Medical, Inc.·00609038200354·BALLARD* Multi-Access Port Catheter, Double Swi...
BD 60ML SYRINGE LUER-LOK TIP
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·December 9, 2019
HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII
FDA 510(k)
FDA Class 2
·Immunology
YUE PFONG SAFETY SYRINGE (3ML)
FDA 510(k)
FDA Class 2
·General Hospital
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 24, 2008
ISOFLEX S
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·September 9, 2011
PELVISOFT ACELLULAR COLLAGEN BIOMESH
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTM·July 18, 2013
IPS e.max ZirCAD CER/in. Prime A2 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758438
FDA Enforcement
Class II
·Ongoing·IVOCLAR VIVADENT AG·May 8, 2024
IPS e.max ZirCAD CER/in. Prime A3 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth Article Number: 758439
FDA Enforcement
Class II
·Ongoing·IVOCLAR VIVADENT AG·May 8, 2024
Halyard Closed Suction System for Adults, Multi-Access¿Port¿Closed¿Suction¿System¿for¿Adults. Used to aspirate liquids or semisolids from a patient's upper airway. a. HALYARD* MULTI-PORT, DSY, ENDO 10FR; b. HALYARD* MULTI-PORT, DSY, ENDO 12FR; c. HALYARD* MULTI-PORT, DSY, ENDO, MDI 12FR; d. HALYARD* MULTI-PORT, DSY, ENDO 14FR; e. HALYARD* MULTI-PORT, DSY, TRACH 14FR; f. HALYARD* MULTI-PORT, DSY, TRACH, WP 14FR; g. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; h. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR; i. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR; j. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; k. HALYARD* MULTI-PORT, DSY, ENDO, MDI 16FR;
FDA Enforcement
Class II
·Terminated·Halyard Health, Inc·April 25, 2018
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025