12 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MOTHERS TOUCH ONE HAND BREAST PUMP
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
REVELATION DIAMOND
FDA UDI
Ss White Burs, Inc.·D6909123552·REVELATION DIAMOND 847-014SC - 5 PACK
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668110898·TIP GUARDS VENTED YELLOW PACK OF 100
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668111116·KATENA INSTRUMENT RACK
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668110874·TIP GUARDS VENTED GREEN PACK OF 100
IMAGE-X SYSTEM
FDA 510(k)
FDA Class 2
·Dental
MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL)
FDA 510(k)
FDA Class 2
·Microbiology
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KNT·October 16, 2024
LEAD LOCKING DEVICE
FDA Adverse Event
Death
·SPECTRANETICS CORPORATION·Product code MFA·January 11, 2013
SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR
FDA Adverse Event
Other
·DEXCOM, INC.·Product code MDS·November 22, 2010
9FR J FEED/GASTRIC DEPR TUBE
FDA Adverse Event
Malfunction
·COVIDIEN·Product code KNT·June 27, 2014
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026