18 results · 22ms · Sources: EU EUDAMED, US FDA

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Zeta Cranial Navigation System (ZNS131-US)

FDA 510(k)
FDA Class 2 ·Neurology

Evolve Masters

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215002299·

Evolve Stem

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215051921·

25-Hydroxy Vitamin Ds EIA

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Revolution Peripheral Atherectomy System

FDA 510(k)
FDA Class 2 ·Cardiovascular

ALARIS SYSTEM

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·November 2, 2023

HEMOSPHERE ALTA

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES·Product code QAQ·November 18, 2025

HEMOSPHERE ALTA

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES·Product code QAQ·August 20, 2025

HEMOSPHERE ALTA

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES·Product code QAQ·November 18, 2025

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 10, 2011

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·November 11, 2014

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·July 23, 2013

HEMOSPHERE ALTA

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES·Product code QAQ·November 18, 2025

G7 SCREW 6.5MM X 35MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code PBI·July 22, 2025

G7 SCREW 6.5MM X 20MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code PBI·July 22, 2025

G7 OSSEOTI 3 HOLE SHELL 50MM D

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·July 22, 2025

HEMASHIELD MICROVEL DOUBLE VELOUR GRAFT

FDA Adverse Event
Death ·MAQUET CARDIOVASCULAR, LLC.·Product code DSY·April 20, 2010

HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR GRAFT

FDA Adverse Event
Death ·MAQUET CARDIOVASCULAR, LLC·Product code DSY·April 20, 2010