20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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