10 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MAR COR COMPLETE WATER TREATMENT SYSTEM FOR KDNEY DIALYSIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BILIARY STONE DISLODGER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HEARING AIDS HB-36M, HB-36MS, HB-36MT, HI-67P, EXCEL-1000
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
GYNECARE GYNEMESH* PS
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTO·February 6, 2013
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 4, 2011
SENSOR ENLITE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·July 21, 2014
BD¿ CHOCOLATE AGAR (GC II AGAR WITH ISOVITALEX¿)
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSO·July 15, 2022
BD¿ CHOCOLATE AGAR (GC II AGAR WITH ISOVITALEX¿), PLATE, 90 MM X 120
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSO·March 29, 2022
PLATE CHOCO GC AGAR W/ISOVITALEX 90MM
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSO·June 1, 2021
PKG, PKG, HOOK SCISSORS, P/N 0250080260. 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