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

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Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U,Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U

FDA 510(k)
FDA Class 2 ·Cardiovascular

TRANSLUX ENERGY

FDA 510(k)
FDA Class 2 ·Dental

SNAP WOUND CARE SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 6, 2025

FLAT TITANIUM PECTUS BAR 10.5

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HRS·March 12, 2025

FLAT TITANIUM PECTUS BAR 12

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HRS·March 12, 2025

MECHANICAL CHAIR/TRANSPORT CHAIR

FDA Adverse Event
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD·Product code INM·October 30, 2014

TREK CORONARY DILATATION CATHETER

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code LOX·August 15, 2011

COHEN INTRAUTERINE PROBE

FDA Adverse Event
Malfunction ·INTEGRA YORK, PA INC.·Product code HCZ·July 2, 2013

FLAT TITANIUM PECTUS BAR 11IN

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HRS·March 12, 2025

QUATERA 700 BIMANUAL I/A HANDPIECE SET

FDA Adverse Event
Injury ·CARL ZEISS MEDITEC AG (OBERKOCHEN)·Product code FSO·September 8, 2023

FLAT TITANIUM PECTUS BAR 13IN

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HRS·March 12, 2025

FLAT TITANIUM PECTUS BAR 13IN

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HRS·March 12, 2025

FLAT TITANIUM PECTUS BAR 11IN

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HRS·January 9, 2025

FLAT TITANIUM PECTUS BAR 11IN

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HRS·January 9, 2025

FLAT TITANIUM PECTUS BAR 11IN

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HRS·January 9, 2025

FLAT TITANIUM PECTUS BAR 12.5

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HRS·January 9, 2025

Achieva TX Interventional Coil 3.0T

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·December 4, 2024

MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

FDA Enforcement
Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·December 15, 2021