8 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ECHO(TM) (QUAD(TM) 7000 MAGNETIC RESONANCE IMAGING SCANNER)
FDA 510(k)
FDA Class 2
·Radiology
PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
AEROSURE MEDIC
FDA 510(k)
FDA Class 2
·Anesthesiology
TERUMO CDI 101 MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTY·December 17, 2010
EEA 31MM SINGLE-USE STAPLER
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY USSC PUERTO RICO, INC.·Product code GAG·July 2, 2014
SURPASS ACETABULAR SYSTEM
FDA Adverse Event
Injury
·STELKAST INC.·Product code JDG·July 14, 2006
ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·January 30, 2014
PKG, KNOT PUSHER 5MM OPEN, P/N 0250080132 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