12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MyoSure MANUAL Tissue Removal Device
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
n/a
FDA UDI
Ortho Development Corporation·00822409113880·5mm Ball Hex Driver 1/4 Square Adapter
ADVIA Centaur® Sample Tips
FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414222608·Pipette tip
TRACTUS TISSUEMAPPER REVIEWER APPLICATION
FDA 510(k)
FDA Class 2
·Radiology
PARI-PATH SURGICAL NAVIGATION SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
PROGRASP (TM) FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·June 17, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 24, 2011
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·October 15, 2014
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code KMW·May 19, 2024
FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the FreeStyle Libre Flash Glucose Monitoring System
FDA Enforcement
Class I
·Ongoing·Abbott Diabetes Care, Inc.·April 12, 2023
FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the FreeStyle Libre Flash Glucose Monitoring System
FDA Recall
Open, Classified
·Abbott Diabetes Care, Inc.·Product code PZE·February 13, 2023
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