37 results
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6ms
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Sources: EU EUDAMED, US FDA
Endoscopic Curved Needle, Surgical Needle Guide, Supplied sterilized by ethylene oxide gas in peel-open packages. Used for internal suturing under direct vision during intraabdominal endoscopic procedures. The needle driver design affords precise placement and control of standard curved suture needles, similar to open abdominal suturing.
FDA Enforcement
Class II
·Terminated·Cook Inc.·June 14, 2017
The VITEK 2 Neisseria-Haemophilus identification card (NH) is intended for use with the VITEK 2 Systems for the automated identification of most clinically significant fastidious organisms. The VITEK 2 NH identification card is a single-use disposable. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.
FDA Enforcement
Class II
·Terminated·BioMerieux SA·June 20, 2018
bioM¿rieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system consisting of instruments, software and reagent cards designed for the ID and antimicrobial susceptibility testing of bacteria and yeast.
FDA Enforcement
Class II
·Terminated·Biomerieux Inc·August 29, 2018
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-PLASTIC CRANIOFACIAL PK-LF, Medline kit SKU DYNJ0395085V; 2) NH PERI DISC PACK, Medline kit SKU DYNJ66311C; 3) DISCECTOMY PACK, Medline kit SKU DYNJ86770; 4) TOTAL KNEE, Medline kit SKU DYNJ909643F.
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·January 21, 2026
Screw Tulip , 5.5mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
6.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
6.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
5.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
6.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
7.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
4.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
7.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
6.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
5.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
7.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
5.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
6.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
5.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012