10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AquaPulse® Irrigation Tubing
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114025·HYDRO-DISSECT FLAT J-SHAPED 27GA (PK/10)
BD 1ML SYRINGE LUER-LOK TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMF·September 26, 2020
Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
QUICKSITE XL LV
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2008
SM104 MSERIES W5TH
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·August 16, 2011
PROGRASP FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·July 12, 2013
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020