14 results · 22ms · Sources: EU EUDAMED, US FDA

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Sensititre Susceptibility Plates

FDA 510(k)
FDA Class 2 ·Microbiology

INFINIA LIGHTSPEED

FDA 510(k)
FDA Class 2 ·Radiology

MYSONO U6 DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

INTELLAMAP ORION

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 15, 2025

SCRDRIVER T8 CYLINDRIC W/GROOVE SHAFT Ø3

FDA Adverse Event
Malfunction ·SYNTHES HAGENDORF·Product code HXX·November 13, 2017

ACCU-CHEK ® SPIRIT COMBO

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LZG·October 6, 2014

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·June 3, 2013

MINICAP

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·June 29, 2011

INTELLAMAP ORION?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·January 30, 2026

INTELLAMAP ORION

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·November 21, 2024

INTELLAMAP ORION?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·February 26, 2026

XIA TITANIUM 4.5 BLOCKER

FDA Adverse Event
Malfunction ·STRYKER SPINE-US·Product code NKB·September 3, 2020

INTELLAMAP ORION

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·December 12, 2024

Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

FDA Enforcement
Class II ·Terminated·Ecolab Inc·September 30, 2015