9 results
·
25ms
·
Sources: EU EUDAMED, US FDA
CHAGAS' IGG ELISA TEST
FDA 510(k)
FDA Class 1
·Microbiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526780811·LEVAMED ACTIVE ANKLE SUP SLVR R III
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0112330·Tap, 5.50mm, Fixed Sleeve
SUPRIS RETROPUBIC SLING SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 30, 2010
MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE
FDA Adverse Event
Death
·ACCESSCLOSURE, INC.·Product code MGB·July 2, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·December 14, 2012
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026