21 results · 33ms · Sources: EU EUDAMED, US FDA

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IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM

FDA 510(k)
FDA Class 2 ·Hematology

ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 100 CONTROL UNIT AND PATIENT ENERGY TRANSFER PADS

FDA 510(k)
FDA Class 2 ·Cardiovascular

MODIFICATION TO: MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

G2 FILTER SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·August 21, 2007

PASS LP

FDA Adverse Event
Injury ·MEDICREA INTL.·Product code MNI·September 16, 2011

APASS LP

FDA Adverse Event
Other ·MEDICREA INTERNATIONAL·Product code MNI·June 15, 2011

PASS LP

FDA Adverse Event
Injury ·MEDICREA INTERNATIONAL·Product code MNI·July 12, 2013

G2 FILTER SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·May 15, 2007

PASS LP

FDA Adverse Event
MEDICREA TECHNOLOGIES·Product code MNI·April 17, 2013

PASS LP

FDA Adverse Event
Injury ·MEDICREA INTERNATIONAL·Product code MNI·November 11, 2011

PASS LP

FDA Adverse Event
Injury ·MEDICREA INTERNATIONAL·Product code MNI·April 5, 2012

VITALITY 2

FDA Adverse Event
Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 11, 2013

FULL FACE MASK

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code MNT·May 22, 2008

PULSE GEN MODEL 102

FDA Adverse Event
Injury ·CYBERONICS, INC.·Product code LYJ·April 8, 2011

RECOVERY G2 FILTER SYSTEM - JUGULAR DELIVERY KIT

FDA Adverse Event
Injury ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·March 23, 2010

PASS LP

FDA Adverse Event
Injury ·MEDICREA TECHNOLOGIES·Product code MNI·April 17, 2013

PASS LP

FDA Adverse Event
Injury ·MEDICREA INTERNATIONAL·Product code MNI·July 12, 2013

PASS LP - LIAPASS

FDA Adverse Event
Injury ·MEDICREA TECHNOLOGIES·Product code MNI·March 29, 2013

G2 FILTER SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·September 21, 2007

CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026