11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MAHE INSTRUMENTS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PANOVIEW
FDA UDI
Richard Wolf GmbH·04055207022870·TELESCOPE 30° Ø 5.3MM WL 303MM rigid, TL 373mm...
SARNS RETROGRADE CANNULA
FDA 510(k)
FDA Class 2
·Cardiovascular
MRT35-SP
FDA 510(k)
FDA Class 2
·Radiology
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·January 3, 2013
HEARTMATE II SYSTEM CONTROLLER
FDA Adverse Event
Malfunction
·THORATEC CORP.·Product code DSQ·November 10, 2010
ACCU-CHEK ® AVIVA
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code NBW·July 15, 2014
THERMA CARE
FDA Adverse Event
Injury
·PROCTER & GAMBLE PAPER PRODUCT CO·Product code IMD·March 6, 2002
Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108 on Siemens ARTISTE, ONCOR and PRIMUS systems. ARTISTE, ONCOR and PRIMUS family of linear accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYE·April 4, 2013
PRIMUS, ONCOR, ARTISTE Linac systems with component 550 TxT Treatment Table. TT-A, TT-D, TT-M or TT-S Table tops. Manufactured by: SIEMENS AG, MEDICAL SOLUTIONS Roentgenstrasse 19-21 Kemnath, GERMANY 95478 The intended use of the SIEMENS branded, ARTISTE", ONCOR" and PRIMUS" family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code JAI·December 5, 2013
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015