20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated Cable
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MAT PLAT,HYDR/ELEC,*SPECIAL*,1100LB
FDA UDI
Hausmann Enterprises, LLC·00840314801197·
MetaSystems Probes
FDA UDI
MetaSystems Probes GmbH·04251315821408·XL TCL1 BA, 10x 100µl, Break Apart Probe
CARTO XP SYSTEM
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, LTD·Product code DQK·November 30, 2007
CARTO XP EP NAVIGATION SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL)·Product code DQK·August 14, 2008
TRIMOTION INJECTOR
FDA 510(k)
FDA Class 1
·Ophthalmic
CARTO XP EP NAVIGATION SYSTEM, SOFTWARE VERISON 8
FDA 510(k)
FDA Class 2
·Cardiovascular
CARTO XP EP NAVIGATION SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER LTD. (HAIFA, ISREAL)·Product code DQK·April 17, 2008
TENDRIL ST
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CRMD·Product code DTB·January 13, 2014
MAYFIELD MODIFIED SKULL CLAMP
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES CORPORATION·Product code HBL·May 30, 2013
UNKNOWN DEPUY ASR CUP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 23, 2011
ADVIA CENTAUR XPT
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·July 19, 2016
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·December 19, 2023
NSK
FDA Adverse Event
Malfunction
·NAKANISHI INC.·Product code EGS·November 10, 2021
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·August 3, 2022
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·February 16, 2023
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·April 25, 2023
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EGS·January 15, 2026
PKG, 3MM INSERT, MARYLAND, FORCEPS CURVED, 29CM, P/N 0250282058 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
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012