30 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FORA D20 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM; TD-3263 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450308134·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450616925·
CT/MR M.A.C. Vaginal Obturator 14cm Length with Lock Screw 1.65G
FDA UDI
MICK RADIO NUCLEAR INSTRUMENT, INC·00817330027979·
AMEDITECH IMMUTEST DRUG SCREEN COC
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DATEX-OHMEDA COMPACT AIRWAY MODULE M-CAIOVX AND M-COVX (VERSION 01) AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Anesthesiology
SOVEREIGN SPINAL SYSTEM
FDA Adverse Event
Injury
·MSD DEGGENDORF MFG·Product code MAX·December 23, 2014
SOVEREIGN SPINAL SYSTEM
FDA Adverse Event
Injury
·MSD DEGGENDORF MFG·Product code MAX·November 22, 2014
SOVEREIGN SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MSD DEGGENDORF MFG·Product code OVD·April 21, 2018
SOVEREIGN SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH·Product code MAX·May 10, 2013
SOVEREIGN SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SWINNEA DC·Product code MAX·February 18, 2011
SOVEREIGN SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MSD DEGGENDORF MFG·Product code OVD·August 9, 2017
VisiPlugST for the Lacrimal Efficiency Test. It is also sold in the EU as CollaSyn Plugs. Model number 1813, 1814, 1815, 1903, 1904, and 1905. This device is cylindrical in shape, approximately 1.75-2.00mm in length, and available in three sizes: 0.3mm, 0.4mm and 0.5mm. Plugs are place in the upper and/or lower horizontal canaliculus. Two plugs are placed into a foam carrier and nitrogen sealed inside a foil pouch. The foil pouch is sent to sterilizer for gamma sterilization. Two sterile pouches are packaged in a box with an IFU.
FDA Enforcement
Class III
·Terminated·Lacrimedics Inc·February 18, 2015
ACCUTORR V MONITOR
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013
RSP SHOULDER
FDA Adverse Event
Injury
·ENCORE MEDICAL, L.P.·Product code KWS·September 16, 2014
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·May 17, 2011
SOVEREIGN¿ SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH·Product code MAX·November 15, 2012
SOVEREIGN SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MSD DEGGENDORF MFG·Product code OVD·November 28, 2017
SOVEREIGN SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MAX·August 19, 2011
SOVEREIGN SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MSD DEGGENDORF MFG·Product code OVD·November 30, 2015