10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MOUTH TO MASK RESUSCITATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
REVELATION DIAMOND
FDA UDI
Ss White Burs, Inc.·D6909126252·REVELATION DIAMOND 850-018M - 5 PACK
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668110867·TIP GUARDS VENTED BLUE PACK OF 100
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668110904·TIP GUARDS VENTED ORANGE PACK OF 100
REPROCESSED UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PG Pro Microcatheter
FDA 510(k)
FDA Class 2
·Cardiovascular
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 14, 2015
ALLEGRETTO WAVE EYE-Q
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code LZS·June 13, 2014
SENSOR, MMT-7002C,10PK GLUCOSE,BSA,17L
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·November 23, 2010
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015