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TeDan Surgical Innovations, Inc.

United States·US-MF-000016933

Last updated September 17, 2026

Information

Country: United States
Address: 12320, Cardinal Meadow Drive, Sugar Land, United States
Website: www.tedansurgical.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 (713) 554-2130
PRRC Contact: Lynne Davies
EUDAMED SRN: US-MF-000016933
FDA FEI Number: 3005726885
DUNS Number: —

Catalogue (2561)

Page 1 of 52

Device	Model / Reference	Registries	Class	Status
Tsi	CS-0326	FDA UDI	Class I	Active
Zimmer	ZS-0056	FDA UDI	Class I	Active
Tsi	TK-1152	FDA UDI	Class I	Active
Tsi	CS-0058-P	FDA UDI	Class I	Active
Tsi	ML-0409	FDA UDI	Class I	Active
Tsi	TK-1241	FDA UDI	Class II	Active
Tsi	LS-0400	FDA UDI	Class I	Active
Tsi	LS-0630	FDA UDI	Class I	Active
Stryker	48871160	FDA UDI	Class I	Active
Tsi	CS-0279	FDA UDI	Class I	Active
Tsi	GS-0268	FDA UDI	Class I	Active
Tsi	LS-0378	FDA UDI	Class I	Active
Stryker	48874100	FDA UDI	Class I	Active
Tsi	LS-0147	FDA UDI	Class I	Active
Stryker	48252200	FDA UDI	Class I	Unknown
Tsi	LS-0764	FDA UDI	Class I	Unknown
Zimmer Mobi-C	0138-LDR	FDA UDI	Class I	Active
Tsi	CS-1297	FDA UDI	Class I	Active
Tsi	TK-1247	FDA UDI	Class II	Active
Tsi	CS-0084-P	FDA UDI	Class I	Active
Stryker	48758003	FDA UDI	Class I	Active
Tsi	CS-0021-P	FDA UDI	Class I	Active
Tsi	ML-0292	FDA UDI	Class I	Active
Tsi	CT-0306	FDA UDI	Class I	Unknown
Tsi	LS-0759	FDA UDI	Class I	Unknown
Tsi	KR-1344	FDA UDI	Class I	Active
Stryker	48252516	FDA UDI	Class I	Unknown
Tsi	KR-1202	FDA UDI	Class I	Unknown
Tsi	ML-0765	FDA UDI	Class I	Active
Stryker	48251812	FDA UDI	Class I	Unknown
Tsi	CS-4096-P	FDA UDI	Class I	Active
Tsi	CS-0075C	FDA UDI	Class I	Active
Stryker	78752702	FDA UDI	Class I	Active
Tsi	TK-1120	FDA UDI	Class I	Active
Zimmer	ZS-0301	FDA UDI	Class I	Unknown
Tsi	CS-1733C	FDA UDI	Class I	Active
Stryker	48873180	FDA UDI	Class I	Active
Stryker	48759000	FDA UDI	Class I	Active
Tsi	CS-1291	FDA UDI	Class I	Active
Lattus	LAT-2002	FDA UDI	Class I	Active
Tsi	LS-0396	FDA UDI	Class I	Active
Tsi	CS-0125	FDA UDI	Class I	Active
Tsi	CS-1333	FDA UDI	Class I	Active
Stryker	48252545	FDA UDI	Class I	Unknown
Zimmer	ZS-0410	FDA UDI	Class I	Active
Tsi	ML-1146	FDA UDI	Class I	Active
Tsi	CS-0155	FDA UDI	Class I	Active
Tsi	ML-0823	FDA UDI	Class I	Unknown
Tsi	ML-0051	FDA UDI	Class II	Active
Tsi	LS-0376	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

TeDan Surgical Innovations B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (13)

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
May 15, 2020	Z-2526-2020	—	terminated	Lack of pouch seal. Product is labelled as sterile.
May 15, 2020	Z-2529-2020	—	terminated	Lack of pouch seal. Product is labelled as sterile.
May 15, 2020	Z-2528-2020	—	terminated	Lack of pouch seal. Product is labelled as sterile.
May 15, 2020	Z-2524-2020	—	terminated	Lack of pouch seal. Product is labelled as sterile.
May 15, 2020	Z-2525-2020	—	terminated	Lack of pouch seal. Product is labelled as sterile.
May 15, 2020	Z-2530-2020	—	terminated	Lack of pouch seal. Product is labelled as sterile.
May 15, 2020	Z-2527-2020	—	terminated	Lack of pouch seal. Product is labelled as sterile.
Jul 16, 2019	Z-1845-2020	—	terminated	There was incorrect raw material used in the production of the identified lot.
Feb 18, 2019	Z-1503-2020	—	terminated	The items identified for recall are labeled as sterile. However, the manufacturer has found that product packaging for the lots listed above may be damaged, potentially exposing the product to non sterile conditions. This situation presents a risk of infection to patients.
Feb 18, 2019	Z-1505-2020	—	terminated	The items identified for recall are labeled as sterile. However, the manufacturer has found that product packaging for the lots listed above may be damaged, potentially exposing the product to non sterile conditions. This situation presents a risk of infection to patients.
Feb 18, 2019	Z-1506-2020	—	terminated	The items identified for recall are labeled as sterile. However, the manufacturer has found that product packaging for the lots listed above may be damaged, potentially exposing the product to non sterile conditions. This situation presents a risk of infection to patients.
Feb 18, 2019	Z-1504-2020	—	terminated	The items identified for recall are labeled as sterile. However, the manufacturer has found that product packaging for the lots listed above may be damaged, potentially exposing the product to non sterile conditions. This situation presents a risk of infection to patients.
Jun 11, 2012	Z-2385-2012	—	terminated	This letter is to notify you that several of our sterile screw products are being voluntarily recalled. Product sterility may be compromised due to a mechanical failure of the protective packaging tube. Tube end plugs may dislodge creating the potential for the screw to come out of the protective tube and then the sharp end of the screw pierce the outer sterile barrier pouch.