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Flexmedics

United States·US-MF-000013090

Last updated May 26, 2026

Information

Country: United States
Address: 40, Linville Way, Franklin, United States
Website: flexmedics.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 317346-6655
PRRC Contact: SaPrina Bemis
EUDAMED SRN: US-MF-000013090
FDA FEI Number: —
DUNS Number: 028853567

Catalogue (23)

Device	Model / Reference	Registries	Class	Status
Reverse Curve Archwire	K880882	FDA 510(k)	Class I	Active
B/A	50-L3-8L-V	FDA UDI	Class II	Active
Extra-oral Headgear	CPRB10	EUDAMED	Class I	Active
Flexmedics Retract Orth Probe, Pettine Bone Probe	K912843	FDA 510(k)	Class I	Active
Center Bend Arch Wires	K881274	FDA 510(k)	Class I	Active
Tin Coated Niti Orthodontic Arch Wires	K885086	FDA 510(k)	Class I	Active
Rectangular Nitinol Arch Wire	K881163	FDA 510(k)	Class I	Active
Flexfinder Guidewire	K943390	FDA 510(k)	Class II	Active
Flexfinder Guidewire	K942074	FDA 510(k)	Class II	Active
Flex Gold	K873649	FDA 510(k)	Class I	Active
Finesse Guidewire Coronary	K952430	FDA 510(k)	Class II	Active
Flexmedics Nitinol Arch Wire	K863742	FDA 510(k)	Class I	Active
Flexmedics Super-Seven Stranded Nickel-Titanium Archwire	K934265	FDA 510(k)	Class I	Active
Flex Plastic Plastic Coated Nitinol Arch Wire	K883120	FDA 510(k)	Class I	Active
Flex Finder Guidewire	K923755	FDA 510(k)	Class II	Active
Flexmedics Guidewire	K893626	FDA 510(k)	Class II	Active
Flexmedics Nitinol Mammory Wire	K870156	FDA 510(k)	N/A	Active
Flexmedics Malleable Cannula	K910674	FDA 510(k)	Class II	Active
Flexfinder Guidewire (regular Shaft/Stiff Shaft) Marked Ink Bands Encap+/Guidewire(regular Shaft/Stiff Shaft) No Marking	K964955	FDA 510(k)	Class II	Active
Flexfinder Guide Wire(regular Shaft/Stiff Shaft) Marked Ink Bands, Flexfinder Guide Wire (regular Shaft/Stiff Shaft) No	K990765	FDA 510(k)	Class II	Active
Flexmedics Guidewire .012 Only	K895899	FDA 510(k)	Class II	Active
Dental Impression Tray	DITAS	EUDAMED	Class I	Active
Dental Wax	PWX536F	EUDAMED	Class I	Active

Related Companies

Authorised Representatives

mdi Europa GmbH DE

Importers

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Notified Bodies

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Authorities

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