11 results
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26ms
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Sources: EU EUDAMED, US FDA
EAR CANNULAS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Alpine SL
FDA UDI
Rmo, Inc.·00885797714572·BIO ALPINE SL BRACHYFACIAL 018 HK/3 5-5 20 EA
Tranquil-C™
FDA UDI
NEXUS SPINE, L.L.C.·B6788222010·Cervical Trial 5x12x12 Lordotic
InSitu Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127029394·Head Trial 22mm x + 0mm
RADIUS MICRO SNARE
FDA 510(k)
FDA Class 2
·Cardiovascular
PROTURA COUCH SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·November 7, 2012
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code FZP·December 3, 2007
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 5, 2015
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
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015