10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COMPLEMENT C1 INACTIVATOR KIT
FDA 510(k)
FDA Class 2
·Immunology
Damon 3
FDA UDI
ORMCO CORPORATION·00889989052749·L3L DAMON 3 .022 0/+5/0 HK
TACTYLON(TM) CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HEMOCARD CONTROL
FDA 510(k)
FDA Class 2
·Hematology
GEMSTR 7 THPY ALT ST
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code FRN·November 4, 2010
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN·Product code CBK·January 9, 2013
AQUACEL EXTRA
FDA Adverse Event
Malfunction
·CONVATEC LIMITED·Product code NAC·February 25, 2014
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NPT·December 2, 2025
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
PKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080120 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