12 results
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19ms
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Sources: EU EUDAMED, US FDA
MICROSCOPE SLIDES
FDA 510(k)
FDA Class 1
·Microbiology
K2-HF DENTINE, D-C3, 50g.
FDA UDI
Yeti Dentalprodukte GmbH·EYET38621120·
SPO2 Module
FDA UDI
Philips Medizin Systeme Böblingen GmbH·00884838021037·The IntelliVue Pulse Oximetry Module: • Produce...
Shoreline™ ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981177447·Modular Trial, 14 x 13 x 12mm, 10 Deg Lordosis
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011862112180·Standard Band, Tooth 45/35, Size 12/Roth 18
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011862112220·Standard Band, Tooth 45/35, Size 12/Roth 22
SUNMED FOLEY CATHETERS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CAAS MRV
FDA 510(k)
FDA Class 2
·Radiology
REVEAL XT
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code DSI·June 10, 2014
ENDOTAK C
FDA Adverse Event
Injury
·HISTORICAL CPI ST. PAUL·Product code NVY·October 8, 2010
VITROS ECI IMMUNODIAGNOSTIC SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code KHO·December 7, 2012
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