30 results · 27ms · Sources: EU EUDAMED, 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