9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RAE II TRACHEAL TUBE
FDA 510(k)
FDA Class 2
·Anesthesiology
MALLINCKRODT
FDA Adverse Event
Malfunction
·COVIDIEN·Product code BTR·August 17, 2016
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471122994·K-WIRE - SINGLE TROCAR 1.4mm DIA x 150mm
LIFE SPINE SACROILIAC JOINT FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PORTABLE NURSING UNIT TERMINAL
FDA 510(k)
FDA Class 2
·Cardiovascular
INRATIO2
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·January 18, 2013
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·December 22, 2010
M2A-MAGNUM PF CUP 58ODX52ID
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·July 17, 2014
PKG, 5MM INSERT, ATRAUMATIC GRASPER FORCEPS, DOUBLE ACTION 45CM, P/N 0250080585 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