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

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CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX

FDA 510(k)
FDA Class 2 ·Anesthesiology

AGXO

FDA UDI
Oticon A/S·05707131286208·H160V2 TI, RITE 312 WL CBE AGXO

Vilex Guidewire

FDA UDI
VILEX IN TENNESSEE, INC.·00841731120588·Guidewire 2.4x150mm Sgl Trocar

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690199526·Modular Knee Straight Reamer - 24mm

Temporary Abutment

FDA UDI
BICON, LLC·00813110021038·5.0 x 4.5mm Temporary Abutment - 2.0mm Post

HS/HG PROSTHETIC SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

CELLSEARCH CIRCULATING TUMOR CELL KIT

FDA 510(k)
FDA Class 2 ·Immunology

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·October 25, 2023

SET, ADMINISTRATION, INTRAVASCULAR

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·June 6, 2016

STOPCOCK MANIFOLD GANGS

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FMG·June 17, 2020

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 19, 2016

FLOGARD

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 6, 2013

3002 SECURE II

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·June 10, 2011

RESTORE ULTRA

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO·Product code LGW·September 3, 2008

MEDTRONIC DUAL CHAMBER TEMPORARY EXTERNAL PACEMAKER 510(K) K150246

FDA Adverse Event
Death ·MEDTRONIC, INC.·Product code DTE·February 10, 2021

ASAHI GLADIUS EX

FDA Adverse Event
Malfunction ·ASAHI INTECC CO., LTD.·Product code DQX·September 17, 2025

ASAHI GLADIUS EX

FDA Adverse Event
Injury ·ASAHI INTECC CO., LTD.·Product code DQX·April 13, 2026

BD¿ NEEDLE 1/2 IN. SINGLE USE, STERILE, 30 G

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·August 10, 2022