12 results
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41ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OMRON OSCILLOMETRIC DIGITAL BLOOD PRESSURE MONIT.
FDA 510(k)
FDA Class 2
·Cardiovascular
Barco
FDA UDI
Barco NV·05415334003040·MDSC-2232 DDI
Barco
FDA UDI
Barco NV·05415334001978·MDSC-2324 MNA
Barco
FDA UDI
Barco NV·05415334001831·MDSC-8358 MNA
MIRAGE ACTIVA MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
PRE-FORMED GUIDEWIRES
FDA 510(k)
FDA Class 2
·Cardiovascular
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 28, 2013
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·December 16, 2010
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code FKX·July 12, 2014
Surgical Display, Model No. MDSC-2224 (24 inch), Model No. MDSC-2226 (26 inch) and Model No. MDSC-2242 (42 inch)
FDA Enforcement
Class II
·Terminated·Barco Inc.·November 11, 2015
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