14 results
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18ms
·
Sources: EU EUDAMED, US FDA
CHART-TYPE MICRO HEMATOCRIT TUBE READER
FDA 510(k)
FDA Class 2
·Hematology
GC Initial™
FDA UDI
Gc America Inc.·15400556702823·GC Initial™ MC Powder Opaque OC2, 50g
GC Initial™
FDA UDI
Gc America Inc.·J0228705111·GC Initial™ MC Powder Opaque OC2, 50g
LEONE SPA
FDA UDI
LEONE SPA·08033707033554·WEB 1ST MOLAR BANDS n.LL 11
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78705111·Mini Sprint Bracket Roth .022" max. 4+5 left
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78705110051·Mini Sprint Bracket Roth .022" max. 4+5 left
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78705110101·Mini Sprint Bracket Roth .022" max. 4+5 left
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78705111001·Mini Sprint Bracket Roth .022" max. 4+5 left
NeoFuse HA Enhanced PLIF/TLIF
FDA 510(k)
FDA Class 2
·Orthopedic
RICHTER MALE LATEX CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TBD
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 12, 2014
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·October 6, 2010
CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·December 12, 2012
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