10 results
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25ms
·
Sources: EU EUDAMED, US FDA
DORMIE NECK SUPPORT SYSTEM
FDA 510(k)
FDA Class 1
·Physical Medicine
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515239555·Freer Septum Knife, E model, 6 3/8"
V-STICK VASCULAR ACCESS SET
FDA 510(k)
FDA Class 2
·Cardiovascular
FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 28, 2013
MINICAP EXTD LIFE TRANS SET W/TWIST CLAMP-EX SHORT
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·December 16, 2010
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 12, 2014
Compress Device Short Anchor Plug, 12 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178554
FDA Enforcement
Class II
·Ongoing·Biomet, Inc.·November 29, 2023
Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all available accessories
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2015
Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander The intended use of the linear accelerator is to deliver x-ray radiation for therapeutic treatment of cancer.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 2, 2014