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Pyng Medical Corp.

US

Last updated May 31, 2026

Information

Country
US
Address
—
Website
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LinkedIn
—
Facebook
—
Email
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Phone
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PRRC Contact
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EUDAMED SRN
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FDA FEI Number
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DUNS Number
253617625

Catalogue (8)

DeviceModel / ReferenceRegistriesClassStatus
FASTTactical FASTT
FDA UDI
Class IIActive
FASTResponder FASTR
FDA UDI
Class IIActive
Fast1 FAST1 Unit
FDA UDI
Class IIActive
Fast1 Intraosseous Infusion System K072487
FDA 510(k)
Class IIActive
F.a.s.t. 1 Intraosseous Infusion System K970380
FDA 510(k)
Class IIActive
Fastresponder Sternal Intraosseous Device K130487
FDA 510(k)
Class IIActive
Fastx Sternal Intraosseous Device K100124
FDA 510(k)
Class IIActive
Fast1 Intraosseous Infusion System K080865
FDA 510(k)
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Nov 5, 2010Z-2687-2011—terminated

Device failed to operate; the insertion of the infusion tube of the FASTx Sternal Intraosseous Device was not achieved in live subjects.