14 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses
FDA 510(k)
FDA Class 2
·Ophthalmic
DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACQA
FDA 510(k)
FDA Class 2
·Radiology
CURLIN INFUSION IV PUMP
FDA Adverse Event
Malfunction
·MOOG MEDICAL DEVICES GROUP·Product code FRN·May 30, 2013
RADIAL JAW¿ 4
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA·Product code FCL·July 23, 2011
COLLEAGUE VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 25, 2008
TRUWAVE, VAMP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·March 20, 2025
TRUWAVE, VAMP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code KRA·April 18, 2025
TRUWAVE, VAMP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·March 20, 2025
SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·May 25, 2021
RELION PEN NEEDLES 4MM X 32 GAUGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·December 12, 2022
RELION PEN NEEDLES 4MM X 32 GAUGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·December 12, 2022
RELION PEN NEEDLES 4MM X 32 GAUGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·December 12, 2022
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012