84 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TERASON T3200 ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Keystone Industries
FDA UDI
Keystone Industries·H66811100201·Large Lingual Bars Pk/12
i.Series®
FDA UDI
HELMER, INC.·00816394021695·Blood Bank Compartmental Access Refrigerator 20...
Fixion Nailing System
FDA UDI
CARBOFIX ORTHOPEDICS LTD·07290109330013·The nail is intended for use in the fixation of...
Fixion Nailing System
FDA UDI
CARBOFIX ORTHOPEDICS LTD·07290109330723·An interlocking intramedullary nail intended fo...
MIRABAY
FDA UDI
Mirabay Orthodontics Corp.·05061075023016·KLEOS 2 PSL METAL MBT 022 UR45 HK PK5 UNI
CORTICAL BONE SCREW 3.5mm x 20mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665033175·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694039925·PrimaLIF Large Cobb, Straight
InSePtion MIS Fixation System
FDA UDI
Kalitec Direct LLC·B07314K0100200·Caddie, Implant
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100200·SNII Screwdriver, Poly Std Assembly
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0100200·Caddie Lid, All Sizes
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0100200·Caddie, Rods, 5.5mm Assembly
DX SERIES FINGER SENSOR
FDA 510(k)
FDA Class 2
·Cardiovascular
NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 7, 2025
RADICAL 7
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·December 18, 2014
RADICAL 7
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·December 18, 2014
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 10, 2024
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·COBAS 4800 BRAF V600 MUTATION TEST
RADICAL-7 COLOR SCREEN HANDHELD
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·May 29, 2015