11 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves
FDA 510(k)
FDA Class 1
·General Hospital
ClearFit
FDA UDI
LONGEVITI NEURO SOLUTIONS LLC·00855113008715·ClearFit 1.4cm Cover
GENERAL SEMEN ANALYSIS KIT
FDA 510(k)
FDA Class 2
·Hematology
DISPOSABLE ELECTRODE
FDA 510(k)
FDA Class 2
·Neurology
MPACT FLAT PE HC LINER Ø32/E
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·February 28, 2018
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 22, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 14, 2014
CA090, DIRECT DRIVE LCA 3/BX
FDA Adverse Event
Malfunction
·APPLIED MEDICAL·Product code FZP·October 23, 2015
SYRINGE 10ML E/T 22G 1-1/2IN TW
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMF·January 3, 2020
BD SYRINGE 10ML E/T 22G 1-1/2IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMF·December 18, 2019
Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021