10 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
GC Reline II
FDA 510(k)
FDA Class 2
·Dental
OrthoMedFlex
FDA UDI
ORTHOMEDFLEX LLC·M7161121532530·Crossbar Acetabular Reamer - 53mm
SILS PORT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HEMOCUE ALBUMIN 201 ANALYZING SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ELECTRODE, PACEMAKER, PERMANENT
FDA Adverse Event
Injury
·RICE CREEK MFG·Product code DTB·June 8, 2013
CLINICAL INFORMATION CENTER
FDA Adverse Event
Injury
·GE HEALTHCARE·Product code DSI·June 30, 2011
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·September 5, 2008
MYSPINE UNILATERAL LEFT GUIDE S01
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code PQC·August 22, 2024
FUSION 8MM-40CM UNSUPP PERIPHERAL GRAFT
FDA Adverse Event
Malfunction
·MAQUET CV·Product code DSY·February 8, 2017
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023