13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Airlock Centrolock Osteosynthesis Implant System
FDA 510(k)
FDA Class 2
·Orthopedic
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL MD-534
FDA 510(k)
FDA Class 2
·Cardiovascular
GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·April 4, 2025
BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·April 4, 2025
BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·April 4, 2025
BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·April 2, 2025
I-STAT E3+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·March 31, 2020
COPIOS PERICARDIUM MEMBRANE
FDA Adverse Event
Injury
·Product code NPL·June 10, 2020
RF ABLATION SYS E SERIES JPN
FDA Adverse Event
Malfunction
·COVIDIEN LP·Product code GEI·October 22, 2014
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORP·Product code MVK·June 18, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 4, 2011
Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·April 27, 2016