8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
IVALON EMBOLIZATION PARTICLES
FDA 510(k)
FDA Class 2
·Neurology
Fixion Nailing System
FDA UDI
CARBOFIX ORTHOPEDICS LTD·07290109331324·Cortical screw for use with humeral nails
WAGNER CONE PROSTHESIS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
INTERSTIM II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·November 12, 2010
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 3, 2014
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·December 21, 2012
PKG, BIPOLAR FORCEPS, PADDLE, 33CM, P/N 0250080361. 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