9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LOWENSTEIN-JENSEN, GRUFT
FDA 510(k)
FDA Class 1
·Microbiology
Vicks RapidRead Digital Thermometer
FDA 510(k)
FDA Class 2
·General Hospital
VPAP ST
FDA 510(k)
FDA Class 2
·Anesthesiology
SURESTEP
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CGA·February 26, 1999
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 30, 2014
MYNX VASCULAR CLOSURE DEVICE
FDA Adverse Event
Injury
·ACCESSCLOSURE, INC.·Product code MGB·October 22, 2010
GYNECARE GYNEMESH* PS
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·December 19, 2012
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020