9 results
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19ms
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Sources: EU EUDAMED, US FDA
DUKKI
FDA 510(k)
FDA Class 1
·Physical Medicine
ReLine
FDA UDI
Nuvasive, Inc.·00195377069368·RELINE C Screw, 3.5x44mm FA
Fixion Nailing System
FDA UDI
CARBOFIX ORTHOPEDICS LTD·07290109331263·Cortical screw for use with humeral nails
ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER
FDA 510(k)
FDA Class 2
·Neurology
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096
FDA 510(k)
FDA Class 2
·Hematology
SOLETRA
FDA Adverse Event
Malfunction
·MEDTRONIC EUROPE SARL·Product code MHY·November 12, 2010
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 3, 2014
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Malfunction
·ALCON- IRVINE TECHNOLOGY CENTER·Product code HQC·December 21, 2012
PKG, BIPOLAR FORCEPS, PADDLE, 33CM, P/N 0250080121 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