10 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LACIMAL INTUBATION SETS
FDA 510(k)
FDA Class 1
·Ophthalmic
LINK Endo-Model EVO Knee System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575267903·Tibial component, cemented, CoCrMo, UHMWPE, sta...
PROVEN REVISION FEMORAL AND PROVEN REVISION TIBIAL INSERT
FDA 510(k)
FDA Class 2
·Orthopedic
IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2
FDA 510(k)
FDA Class 2
·Anesthesiology
RENU WITH MOISTURELOC NO RUB
FDA Adverse Event
Other
·BAUSCH LOMB·Product code LPN·September 4, 2006
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·March 6, 2014
RX ACCULINK CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIM·November 14, 2012
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 8, 2010
Ingenia 3.0T CX-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: 781271
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015