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

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ANEROID SPHYGMOMANOMETERS/MERCURIAL SPHYGMOMANOMETERSRS

FDA 510(k)
FDA Class 2 ·Cardiovascular

Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

IPLAN! DIGITAL TEMPLATING

FDA 510(k)
FDA Class 2 ·Neurology

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code EFB·February 15, 2023

EASYTRAK 2

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code OJX·February 4, 2013

GUT SURGICAL SUTURE

FDA Adverse Event
Injury ·ETHICON, INC.·Product code GAL·December 23, 2010

PIPELINE EMBOLIZATION DEVICE

FDA Adverse Event
Malfunction ·EV3 NEUROVASCULAR·Product code OUT·July 17, 2014

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code EFB·July 26, 2024

NSK

FDA Adverse Event
Malfunction ·NAKANISHI INC.·Product code EFB·September 17, 2025

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code EFB·February 18, 2019

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code EFB·February 18, 2019

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code EFB·February 18, 2019

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS25; b) NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS30; c) NEONATAL TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS35; d) NEONATAL TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS40

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024