22 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NMI PICC III
FDA 510(k)
FDA Class 2
·General Hospital
NOVO Health Services, LLC
FDA UDI
NOVO HEALTH SERVICES, LLC·00812564031815·Basin Set, Small
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450387245·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197527064·Super-Cut Stevens Tenotomy Scissors
15.0 c...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197038898·Super-Cut Stevens Scissor
11.0cm...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197380850·Super-Cut Jabaley Scissors
curved...
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970379·
EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR
FDA 510(k)
FDA Class 2
·Immunology
OXIMAX MAX-FAST ADHESIVE FOREHEAD SENSOR
FDA 510(k)
FDA Class 2
·Cardiovascular
PEN NDL 32G 4MM PRO 100 BOX 1200 US
FDA Adverse Event
Malfunction
·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·March 13, 2025
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE·Product code ITI·July 27, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·May 20, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 26, 2014
LIBERTE' CORONARY STENT DELIVERY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code MAF·June 13, 2011
ANCHOR BOLTS
FDA Adverse Event
Malfunction
·AD-TECH MEDICAL INSTRUMENT CORP.·Product code GZL·May 17, 2019
Siemens Artis Q biplane---Interventional Fluoroscopic X-Ray System Model Number: 10848282
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 10, 2019
AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: AXIOM Artis zee and Q/Q.zen 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. Procedures that can be performed with the AXIOM Artis zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·April 6, 2016
Artis Q/ Q zen systems; Artis Q/ Q zen systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·April 22, 2015
Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Model No. 10848280; Artis Q zeego, Model No. 10848283 Product Usage: 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·March 25, 2020
Artis Q biplane, Model Number 10848282
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022