13 results
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20ms
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Sources: EU EUDAMED, US FDA
BLADE SAFE
FDA 510(k)
FDA Class 2
·General Hospital
Marienfeld Superior
FDA UDI
Paul Marienfeld GmbH & Co. KG·04250317353818·
Unimed
FDA UDI
Unimed Medical Supplies, Inc.·06936735456383·Reusable Multi-site Y-shape SpO2 Sensor Comen-N...
TSRH® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978947976·CROSSLINK 810-208 5.0 LP CLK PT A L 1.50
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345023918·PADDLE SPREADER, 8MM
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0102080·Shaver, Open 8mm
iNSitu™ Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127020391·Neck Trial, Size 8, Lateral
DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Disposable Endoscopic Trocar
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 4, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 9, 2007
MESH
FDA Adverse Event
Injury
·Product code FTM·October 31, 2012
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018