13 results · 29ms · Sources: EU EUDAMED, US FDA

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STEELEX ELECTRODE SET

FDA 510(k)
FDA Class 2 ·Cardiovascular

TruForm

FDA UDI
Rmo, Inc.·00885797100009·MN 1MOL BD KT STD N/L UNIV 176

BUSCH®, BNA®

FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120305561·Diamond, cone flat, medium grit

HARDYDISK AMOXICILLIN/CLAVULANIC ACID, 20/10MCG

FDA 510(k)
FDA Class 2 ·Microbiology

ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 2, 2013

VASOVIEW HEMOPRO EVH SYSTEM

FDA Adverse Event
Injury ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·March 18, 2011

MALLINCKRODT

FDA Adverse Event
Malfunction ·COVIDIEN·Product code BTS·July 14, 2014

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

Spirit Plus Bed, A-C Powered Hospital Bed

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

Spirit Select Bed, A-C Powered Hospital Bed

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013