26 results
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39ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFIED DSL-2300 ACTH RIA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
3M™ Unitek™
FDA UDI
3M COMPANY·30605861027497·3M™ Unitek™ Stainless Steel First Primary Molar...
TruForm
FDA UDI
Rmo, Inc.·00885797099679·MAN MOLAR BDS PEDO ASST 100
ROC Crown 3LR
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199001470·
TensCare
FDA UDI
TENSCARE LIMITED·05033435135776·The Nouri Digital Electric Breast Pump is a pow...
EDENTA
FDA UDI
EDENTA ETABLISSEMENT·E312K90044710001·Dowel Pin 17 mm
Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared by the FDA, and until then can only be used as an investigational device.
FDA Enforcement
Class II
·Terminated·Neuro Kinetics, Inc.·September 9, 2015
Elite®
FDA UDI
Ortho Organizers, Inc.·00190707050863·.022/045 U6R CBT (MC)
CTC DVT-1 CALF GARMENT, MODEL DVT-1
FDA 510(k)
FDA Class 2
·Cardiovascular
BLOOD MONITORING UNIT, MODEL BMU 40
FDA 510(k)
FDA Class 2
·Cardiovascular
Mariner
FDA UDI
Seaspine Orthopedics Corporation·10889981133009·Solid Tap 4.75mm, A/O
Mariner
FDA UDI
Seaspine Orthopedics Corporation·10889981132842·Solid Tap 4.75mm, 1/4 sq
Mariner
FDA UDI
Seaspine Orthopedics Corporation·10889981133320·Solid Tap 4.75mm, 1/4 sq, Short
Mariner
FDA UDI
Seaspine Orthopedics Corporation·10889981133160·Solid Tap 4.75mm, Tri-Flat
Mariner
FDA UDI
Seaspine Orthopedics Corporation·10889981133481·Solid Tap 4.75mm, 1/4 sq, Long
Mariner
FDA UDI
Seaspine Orthopedics Corporation·10889981133788·Cannulated Tap 4.75mm, A/O
Mariner
FDA UDI
Seaspine Orthopedics Corporation·10889981128791·Cannulated Tap Long, Dia 4.75mm
Mariner
FDA UDI
Seaspine Orthopedics Corporation·10889981134235·Cannulated Tap Long, Dia 4.75mm
Mariner
FDA UDI
Seaspine Orthopedics Corporation·10889981133931·Cannulated Tap 4.75mm, Tri-Flat
Mariner
FDA UDI
Seaspine Orthopedics Corporation·10889981134082·Cannulated Tap 4.75mm, 1/4 sq, Short