26 results · 23ms · Sources: EU EUDAMED, US FDA

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Xprecia Stride Coagulation System, Xprecia System PT Controls

FDA 510(k)
FDA Class 2 ·Hematology

POWERNEB

FDA 510(k)
FDA Class 2 ·Anesthesiology

AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ROI-C IMPLANT, UNKNOWN SIZE

FDA Adverse Event
Malfunction ·LDR MEDICAL·Product code OVE·February 4, 2020

ROI-C BI-PACK CAGE PRE-FILLED WITH BF+ BONE SUBSTITUTE H6MM 14X17MM

FDA Adverse Event
Malfunction ·LDR MÉDICAL·Product code OVE·April 13, 2020

ROI-C BI-PACK CAGE PRE-FILLED WITH BF+ BONE SUBSTITUTE H5MM 14X15.5MM

FDA Adverse Event
Malfunction ·LDR MEDICAL·Product code OVE·August 6, 2020

SINGLE PM KIT VAMP PLUS

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·July 7, 2011

GOBED II MED/SURG BED

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·June 7, 2013

FENWAL COLLECTION BAG

FDA Adverse Event
Malfunction ·FENWAL, INC.·Product code KSR·September 5, 2008

ROI-C IMPLANT, UNKNOWN SIZE

FDA Adverse Event
Injury ·LDR MÉDICAL·Product code OVE·August 24, 2021

MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL

FDA Adverse Event
Injury ·WILLIAM COOK EUROPE·Product code KRD·April 28, 2021

BD KIESTRA IDENTIFA

FDA Adverse Event
Malfunction ·BD KIESTRA LAB AUTOMATION·Product code QBN·October 8, 2025

MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL

FDA Adverse Event
Malfunction ·WILLIAM COOK EUROPE·Product code KRD·September 12, 2018

MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL

FDA Adverse Event
Malfunction ·WILLIAM COOK EUROPE·Product code KRD·September 14, 2018

FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·WILLIAM COOK EUROPE·Product code KRD·September 14, 2018

SPACER, UNKNOWN SIZE

FDA Adverse Event
Injury ·LDR MEDICAL·Product code ODP·August 23, 2019

FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM

FDA Adverse Event
Injury ·WILLIAM COOK EUROPE·Product code KRD·April 23, 2021

MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL

FDA Adverse Event
Injury ·WILLIAM COOK EUROPE·Product code KRD·June 14, 2021

MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL

FDA Adverse Event
Injury ·WILLIAM COOK EUROPE·Product code KRD·April 26, 2021

ROI-C IMPLANT, UNKNOWN SIZE

FDA Adverse Event
Injury ·LDR MÉDICAL·Product code OVE·September 21, 2021