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EPIMED INTERNATIONAL, INC.

United States·US-MF-000010774

Last updated September 17, 2026

Information

Country: United States
Address: 13958, Diplomat Drive, Farmers Branch, United States
Website: epimed.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Preston Frasier
EUDAMED SRN: US-MF-000010774
FDA FEI Number: 1316297
DUNS Number: —

Catalogue (191)

Page 3 of 4

Device	Model / Reference	Registries	Class	Status
Flexible Spinal Needle	K043467	FDA 510(k)	Class II	Active
Quincke Spinal Needle	K022029	FDA 510(k)	Class II	Active
Epimed International, Inc.	134-1430	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	155-2350	EUDAMEDFDA UDI	Class IIb	Active
Epimed International, Inc.	243-1815	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	257-1610	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	136-1730	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	233-1610	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	282-2010	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	164-2024	EUDAMEDFDA UDI	Class IIb	Active
Epimed International, Inc.	281-2015	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	125-1820T	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	126-2060	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	106-1312	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	116-2045	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	134-1420	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	125-2060T	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	106-1518	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	135-1455	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	282-1610	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	120-2245	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	256-2205	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	107-1613	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	155-2393	EUDAMEDFDA UDI	Class IIb	Active
Epimed International, Inc.	120-2235	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	126-2025	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	257-2010	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	121-2535	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	106-1314	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	259-2010	EUDAMED	Class IIa	Active
Epimed International, Inc.	109-1413	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	120-2525	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	166-2036	EUDAMEDFDA UDI	Class IIb	Active
Epimed International, Inc.	125-1635T	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	157-1924	EUDAMEDFDA UDI	Class IIb	Active
Epimed International, Inc.	108-1415	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	122-2080	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	257-1815	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	155-2542	EUDAMEDFDA UDI	Class IIb	Active
Epimed International, Inc.	159-2112	EUDAMEDFDA UDI	Class IIb	Active
Epimed International, Inc.	257-1615	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	108-1416	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	105-1618	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	194-2036	EUDAMEDFDA UDI	Class IIb	Active
Epimed International, Inc.	131-2235	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	106-1615	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	116-2525	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	287-2210	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	117-2245	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	242-2205	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (11)

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

Date	Recall No.	Class	Status	Reason
Feb 1, 2021	Z-1276-2021	—	terminated	Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off
Feb 21, 2020	Z-1849-2020	—	terminated	Incorrect expiration date on introduction cannula packaging.
Feb 21, 2020	Z-1850-2020	—	terminated	Incorrect expiration date on introduction cannula packaging.
Jun 18, 2019	Z-2068-2019	—	terminated	Mislabeled - The product's labeling contains an incorrect size for the catheter included in the kit. The kit contains a 21 gauge catheter, however the labeling states a 12 gauge catheter is included.
Jun 18, 2019	Z-2069-2019	—	terminated	Mislabeled - The product's labeling contains an incorrect size for the catheter included in the kit. The kit contains a 21 gauge catheter, however the labeling states a 12 gauge catheter is included.
Dec 28, 2017	Z-2313-2021	—	completed	Potential for stylet to protrude from the distal end of the catheter
Dec 28, 2017	Z-2312-2021	—	completed	Potential for stylet to protrude from the distal end of the catheter
Jul 24, 2017	Z-0087-2018	—	terminated	Potential for partially incomplete seal of product, impacting sterility.
Jul 24, 2017	Z-0088-2018	—	terminated	Potential for partially incomplete seal of product, impacting sterility.
Jul 24, 2017	Z-0089-2018	—	terminated	Potential for partially incomplete seal of product, impacting sterility.
Apr 22, 2016	Z-0086-2017	—	terminated	There is a possibility that the needles may have the potential to skive a catheters outer coating. If this were to occur, there exists the risk that a portion of the catheter could remain in the patient, which may require otherwise unnecessary medical invention.