18 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU
FDA 510(k)
FDA Class 3
·Cardiovascular
Anovo ARMS Entry Guide
FDA UDI
MOMENTIS SURGICAL LTD·07290018151235·The AnovoTM Surgical System is a robotic-assist...
KSEA UNIVERSAL LAPAROMAT LAPAROSCOPIC SUCTION AND IRRIGATION PUMP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DYMEDIX REUSABLE AIRFLOW/SNORE SENSOR
FDA 510(k)
FDA Class 2
·Anesthesiology
ETEST FLUCONAZOLE FL 256 WW S30
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code NGZ·May 7, 2021
ETEST FLUCONAZOLE FL 256 WW S30
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code NGZ·May 7, 2021
ETEST FLUCONAZOLE FL 256 WW S30
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code NGZ·May 7, 2021
ETEST FLUCONAZOLE FL 256 WW S30
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code NGZ·May 7, 2021
ETEST FLUCONAZOLE FL 256 WW S30
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code NGZ·May 7, 2021
ETEST FLUCONAZOLE FL 256 WW S30
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code NGZ·May 7, 2021
ETEST FLUCONAZOLE FL 256 WW S30
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code NGZ·May 7, 2021
ETEST FLUCONAZOLE FL 256 WW S30
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code NGZ·May 7, 2021
PORTEX RSP TRACHEAL TUBE HOLDERS
FDA Adverse Event
Malfunction
·SMITHS MEDICAL INTL LTD·Product code JAY·March 12, 2013
TERUMO CDI 540 CALIBRATOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·March 18, 2011
CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code KRH·May 9, 2008
BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·June 1, 2023
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013