9 results
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25ms
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Sources: EU EUDAMED, US FDA
PIN DOT FLIP-DOWN ABDUCTOR
FDA 510(k)
FDA Class 1
·Physical Medicine
REVELATION DIAMOND
FDA UDI
Ss White Burs, Inc.·D6909135452·REVELATION DIAMOND 878-012C - 5 PACK
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221
FDA 510(k)
FDA Class 2
·Hematology
VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL SYSTEM COOLPLUSE 90 AND COOLPLUSE 90 WITH HAN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RESTORE RECHARGABLE NEUROSTIMULATOR
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·November 12, 2010
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 3, 2014
CUSTOM PAK
FDA Adverse Event
Malfunction
·ALCON- BELGIUM/S.A.ALCON-COUVREUR N.V.·Product code KYG·December 21, 2012
BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·January 4, 2022
PKG, RING HANDLE, P/N 0250080236. 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