9 results
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26ms
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Sources: EU EUDAMED, US FDA
LATEX EXAMINATION GLOVES, POWDER FREE
FDA 510(k)
FDA Class 1
·General Hospital
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150737·K-WIRE - SINGLE TROCAR 1.0mm DIA x 150mm
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482148631·Retraction Grasper 5.0 mm
10-SECOND DIGITAL THERMOMETER, MODELS ST87, ST89, ST80, ST88
FDA 510(k)
FDA Class 2
·General Hospital
TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·April 24, 2014
UNKNOWN DEPUY POLY ACETABULAR LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWY·February 4, 2013
ACCU-CHEK FLEXLINK INFUSION SET
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·December 8, 2010
PKG, 5MM SHAFT, NEEDLE HOLDER, CURVED RIGHT, 45CM, P/N 0250080590 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