9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Country: Israel
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Black Box Voice Medical Ltd.
Manufacturer
🇮🇱 Israel·1 Basic UDI-DI·1 Device
BBV APP
Device
EU MDD
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Eu Md Class 1
·Black Box Voice Medical Ltd.·On the market
TrueDent-D
Basic UDI-DI
EU MDR
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Eu Md Class 1
·Stratasys Ltd.·5 devices
CloseFit™ Metal Surgical Box - Small
Device
EU MDR
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Eu Md Class 2a
·Adin Dental Implant Systems LTD.·On the market·32 countries
CloseFit™ Metal Surgical Box - Big
Device
EU MDR
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Eu Md Class 2a
·Adin Dental Implant Systems LTD.·On the market·32 countries
BBV APP
Basic UDI-DI
EU MDD
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Eu Md Class 1
·Black Box Voice Medical Ltd.·1 device
PoleStar system (N20 / N30) Warning Lamps Control Box, Warning Lamps Control Box Cables, Thermoflex Chiller Product The PoleStar Surgical MRI System is intended for use as an intraoperative imaging device to produce MRI images of sections of the head selected by the physician.
FDA Enforcement
Class II
·Terminated·Medtronic Navigation·July 13, 2016
Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body fluids for surgical use.
FDA Enforcement
Class III
·Terminated·Degania Silicone, Ltd.·March 14, 2018
The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.
FDA Enforcement
Class I
·Terminated·Lumenis Limited·February 20, 2013