10 results · 19ms · Sources: EU EUDAMED, US FDA

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TraumaCad Neo (1.1)

FDA 510(k)
FDA Class 2 ·Radiology

AETREX WORLDWIDE, INC.

FDA registration
AETREX WORLDWIDE, INC.·1 product·🇺🇸 United States

Portrait VSM

FDA 510(k)
FDA Class 2 ·Cardiovascular

Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ALARIS SYSTEM

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·November 9, 2023

BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code FMI·March 18, 2024

ONE TOUCH ULTRA2 METER

FDA Adverse Event
Injury ·LIFESCAN, INC.·Product code NBW·November 24, 2008

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 12, 2011

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 23, 2013

PKG, PKG, HOOK SCISSORS, P/N 0250080260. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

FDA Enforcement
Class II ·Terminated·Stryker Endoscopy·December 24, 2014