12 results
·
27ms
·
Sources: EU EUDAMED, US FDA
TECHNICON RA-1000 SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
n/a
FDA UDI
Hager & Meisinger Gesellschaft mit beschränkter Haftung·E0HM510B8333140231·Rotary diamond instrument for dental application
n/a
FDA UDI
Hager & Meisinger Gesellschaft mit beschränkter Haftung·E0HM51008333140231·Rotary diamond instrument for dental application
INTERMITTENT URETHRAL CATHETERS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6
FDA 510(k)
FDA Class 2
·Cardiovascular
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL- NEUROMODULATION·Product code GZB·December 10, 2013
JETSTREAM SC
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code MCW·January 31, 2023
12MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HSB·October 10, 2017
FRESENIUS 2008K2 MACHINE
FDA Adverse Event
Malfunction
·CONCORD MANUFACTURING·Product code KDI·March 25, 2014
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES·Product code MIH·November 2, 2012
OCTRODE LEAD
FDA Adverse Event
Injury
·ADVANCED NEUROMODULATION SYSTEMS, INC.·Product code LGW·September 2, 2010
OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370
FDA Enforcement
Class II
·Ongoing·Osteomed, LLC·December 15, 2021