14 results · 20ms · Sources: EU EUDAMED, US FDA

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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