10 results
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18ms
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Sources: EU EUDAMED, US FDA
TRANSFER-AID(TM)
FDA 510(k)
FDA Class 2
·General Hospital
REVELATION DIAMOND
FDA UDI
Ss White Burs, Inc.·D6909139852·REVELATION DIAMOND 905-018F-S - 5 PACK
SINGLE-USE LAPAROSCOPIC SUCTION/IRRIGATION CANNULA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MACHNET BILATERAL OPEN BREAST COIL. CATALOG # MICS-GSXX
FDA 510(k)
FDA Class 2
·Radiology
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·January 14, 2013
CHARITE SIZE 3 SLIDING CORE 7.5MM
FDA Adverse Event
Injury
·DEPUY SPINE INC.·Product code MJO·November 30, 2010
SELOX ST 60
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVN·July 3, 2014
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·September 18, 2024
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
VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The Software CD will be individually packaged using a standard CD plastic case and placed into a standard CD mailer The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile body fluids.
FDA Recall
Terminated
·Trek Diagnostic Systems·Product code MDB·July 23, 2012