14 results · 19ms · Sources: EU EUDAMED, US FDA

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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