10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ORIGIN PREPERITONEAL DISSECTION BALLOON SYSTEM (PDBS)--EXTRA
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GALAXY FIXATION GEMINI
FDA UDI
ORTHOFIX SRL·18053340348881·GALAXY FIXATION GEMINI STERILIZATION TRAY BASE
The Orthodontic Store
FDA UDI
Young Innovations, Inc.·00840326406687·Pf Tray Lg Upr #2
RADspeed Pro
FDA UDI
SHIMADZU CORPORATION·04540217052363·
CINEMAC QAS
FDA 510(k)
FDA Class 2
·Radiology
ALAMAR BACTERIAL IDENTIFICATION TEST PANEL
FDA 510(k)
FDA Class 1
·Microbiology
CONSERVE(R) PLUS CUP
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code KWA·February 6, 2013
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·January 4, 2011
6.0MM TI HARD ROD 75MM
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code NKB·July 21, 2014
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