20 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D
FDA 510(k)
FDA Class 2
·Cardiovascular
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017811·K-Wire, Double Ended, Trocar Point, Diameter Si...
SSW CARBIDE TRIMMING AND FINISHING
FDA UDI
Ss White Burs, Inc.·D6901603352·20 BLADE FINISHING CARBIDE SAFE END SE8 - 5 PACK
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613084837·K-Wire, Double Ended, Trocar Point, Diameter 0....
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017828·K-Wire, Double Ended, Trocar Point, Diameter 0....
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306820434·Allis Forceps, 5x6 Teeth, 30.5cm
World Smart Card Size 7
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215046347·
ORS VISUAL
FDA 510(k)
FDA Class 2
·Radiology
FILE-EZE
FDA 510(k)
FDA Unclassified
·Unknown
BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code NGT·November 12, 2021
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·January 15, 2021
UNKNOWN STAPLING DEVICE
FDA Adverse Event
Injury
·US SURGICAL PUERTO RICO·Product code GDW·October 31, 2020
CONSULTA CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 10, 2013
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·July 13, 2011
REFURBISHED COLLEAGUE VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 16, 2008
Siemens Artis zeego--Interventional Fluoroscopic X-Ray System Model Number: 10280959
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 10, 2019
Artis zeego, Model Number 10280959
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019
Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 10, 2014
Siemens Artis zee systems; 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·August 12, 2015