141 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SEAL ONE
FDA 510(k)
FDA Class 2
·Cardiovascular
n.a.
FDA UDI
Karl Storz GmbH & Co. KG·04048551054161·FARRIOR Ear Speculum, Ø 8 mm
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120700·Steinmann Pin 3.5x230mm (9/64 x 9")
SMARTPILOT VIEW MODEL MK04500
FDA 510(k)
FDA Class 2
·Anesthesiology
SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER
FDA 510(k)
FDA Class 2
·Dental
ALARIS PUMP MODULE
FDA Adverse Event
Injury
·CAREFUSION CORPORATON·Product code FRN·June 8, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 21, 2013
ARCHITECT HBSAG QUALITATIVE II
FDA Adverse Event
Malfunction
·ABBOTT IRELAND·Product code KSJ·September 26, 2014
ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code FGE·December 13, 2024
ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code FGE·October 24, 2024
ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code FGE·October 17, 2023
Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354 Artis Q.zen Floor, Model No. 10848353 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
ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code GBO·October 11, 2021
ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code FGE·July 1, 2024
ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code FGE·July 5, 2024
ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code FGE·August 6, 2020
ULTRATHANE BILIARY DRAINAGE CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code GBO·August 11, 2020
ULTRATHANE BILIARY DRAINAGE CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code GBO·August 11, 2020
ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code FGE·November 30, 2020
ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code FGE·October 14, 2020