14 results
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20ms
·
Sources: EU EUDAMED, US FDA
Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517632067·CoRoent Ant TLIF Ti, 15x12x34mm 12°
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197176620·Kuhn-Bolger Biopsy Forceps
2x4mm,...
ZIIP+ Device
FDA 510(k)
FDA Class 2
·Neurology
Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover
FDA 510(k)
FDA Class 2
·Neurology
ACCU-CHEK D-TRONPLUS
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS·Product code LZG·July 21, 2009
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Injury
·ROCHE DIABETES CARE AG·Product code LZG·March 1, 2013
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 17, 2011
CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·November 14, 2014
HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code KNQ·July 24, 2013
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·March 20, 2019
ACCU-CHEK ULTRAFLEX INFUSION SET
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS·Product code FPA·March 17, 2009
ACCU-CHEK SPIRIT CARTRIDGE
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS·Product code LZG·March 17, 2009
dS Breast 7ch 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024