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