11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CUPTIMIZE Advanced
FDA 510(k)
FDA Class 2
·Radiology
Symmetry Sauerbruch
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482060148·Symmetry® Retractor, Sauerbruch, 2 7/8 in Deep,...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0315030·Probe, 1.5 inch Ball, Steffee, Curved, Impaction
HNM Medical
FDA UDI
HNM STAINLESS, LLC.·00842962114186·SAUERBRUCH RETRACTOR, 9", #3, 13/16"X2 7/8" BLADES
AVITA TS8/TS9 SERIES IR EAR/FOREHEAD THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
SE-601 SERIES ELECTROCARDIOGRAPH
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 21, 2025
SM204 M-SERIES W/BIG WHEEL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·July 22, 2011
FLO-GARD 6301 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·November 18, 2008
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code MHY·July 17, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022