23 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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DYNAMIC DU SERIES PORTABLE DENTAL UNIT
FDA 510(k)
FDA Class 1
·Dental
POLYPERF SAFE
FDA UDI
PEROUSE MEDICAL·03661234014101·
MAXCUT CARBIDE BUR (100/pk) FG 2
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D77811119071·MAXCUT CARBIDE BUR (100/pk) Shape: Round; Size:...
HiJAK™ Cervical
FDA UDI
ATLAS SPINE, INC.·M68111190700090·9mm SM Fixed 5° Lordotic, HiJAK™ Cervical
HiJAK™ Cervical
FDA UDI
ATLAS SPINE, INC.·M68111190700140·14mm SM Fixed 5° Lordotic, HiJAK™ Cervical
HiJAK™ Cervical
FDA UDI
ATLAS SPINE, INC.·M68111190700110·11mm SM Fixed 5° Lordotic, HiJAK™ Cervical
HiJAK™ Cervical
FDA UDI
ATLAS SPINE, INC.·M68111190700080·8mm SM Fixed 5° Lordotic, HiJAK™ Cervical
HiJAK™ Cervical
FDA UDI
ATLAS SPINE, INC.·M68111190700100·10mm SM Fixed 5° Lordotic, HiJAK™ Cervical
HiJAK™ Cervical
FDA UDI
ATLAS SPINE, INC.·M68111190700130·13mm SM Fixed 5° Lordotic, HiJAK™ Cervical
HiJAK™ Cervical
FDA UDI
ATLAS SPINE, INC.·M68111190700120·12mm SM Fixed 5° Lordotic, HiJAK™ Cervical
HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
TROCHANTERIC NAIL KIT, TI GAMMA3 11X200MM X 120
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·January 8, 2013
HAHN TAPERED IMPLANT Ø3.5 X 13 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 28, 2024
HAHN TAPERED IMPLANT Ø3.5 X 13 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·April 29, 2024
VITEK® 2 AST-ST01 TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC·Product code LON·October 24, 2017
ADVIA CENTAUR XP TROPONIN ULTRA ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·May 14, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·September 23, 2014
ASCENSIA BREEZE2
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·August 8, 2008
SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022