14 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Modus Nav
FDA 510(k)
FDA Class 2
·Neurology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517639059·CoRoent Ant TLIF PEEK, 8x13x32mm 15°
N-600X WITH SPD, OXIMAX N-600X
FDA 510(k)
FDA Class 2
·Cardiovascular
IDS-ISYS INTACT PTH
FDA 510(k)
FDA Class 2
·Clinical Chemistry
UPJ OCCLUSION BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code EZL·December 6, 2021
STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·August 16, 2019
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 18, 2014
TOTAL ASR ACET IMP SIZE 52
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·June 21, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 28, 2011
UPJ OCCLUSION BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code EYB·July 2, 2024
UPJ OCCLUSION BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code EZL·February 28, 2022
UPJ OCCLUSION BALLOON CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code EZL·July 8, 2022
UPJ OCCLUSION BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code EZL·January 15, 2021
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026