20 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ACUSON X800 Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
X-CORE
FDA UDI
Nuvasive, Inc.·00887517426543·X-CORE 2 Ti Core, Ø18x41-67mm
OsteoMed
FDA UDI
OSTEOMED LLC·00845694091008·Bur Hole Plate, Small
ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 27, 2011
RSP SHOULDER
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code KWS·June 13, 2013
PUMP MMT-522NAP PRDGM INS V2.2 PL EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·September 26, 2008
PROTECTION SLEEVE FOR FNS INSERTION INSTRUMENTS
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code GEA·September 3, 2019
FEMORAL NECK SYSTEM INSERTION HANDLE
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code KTT·September 3, 2019
4.3MM DRILL BIT LENGTH 413MM
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code GFG·September 3, 2019
INSERT FOR FNS INSERTION HANDLE
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code KTT·September 3, 2019
PROTECTION SLEEVE FOR FNS INSERTION INSTRUMENTS
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code GEA·December 16, 2020
Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·June 15, 2022
ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for single and biplane diagnostic imaging and interventional procedures.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·March 3, 2021
Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·July 13, 2022
Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·February 2, 2022
Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327600
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022
ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·November 11, 2020