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TeDan Surgical Innovations, Inc.

United States·US-MF-000016933

Last updated September 17, 2026

What TeDan Surgical Innovations, Inc. makes

TeDan Surgical Innovations, Inc. manufactures reusable surgical instruments and systems, including instrument trays, nail scissors, hand-held retractors, and surgical retraction systems. Their portfolio also includes dental drill bits, endoscopic light source units, and sterilization/disinfection containers. Specific products range from neuro retraction arms and distraction screwdrivers to conical discetomy blades and cannulated blade sets.

The company’s devices are classified as Class I, Class II, and Class IIa under regulatory frameworks, with listings in the EU’s eudamed database and the FDA’s 510(k) registry. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does TeDan Surgical Innovations, Inc. manufacture?

TeDan Surgical Innovations, Inc. specializes in reusable surgical instruments and systems. Their portfolio includes instrument trays, nail scissors, hand-held retractors, and surgical retraction systems. They also produce dental drill bits, endoscopic light source units, and sterilization/disinfection containers. Examples of their products range from neuro retraction arms and distraction screwdrivers to specialized blades like conical discetomy blades and cannulated blade sets.

Where is TeDan Surgical Innovations, Inc. based?

TeDan Surgical Innovations, Inc. is based in the United States. This location influences their regulatory compliance, particularly for devices marketed in the U.S. and globally, such as those listed in the FDA’s 510(k) registry.

Which regulatory registries list TeDan Surgical Innovations, Inc.’s devices?

TeDan Surgical Innovations, Inc.’s devices are listed in two key regulatory databases: the EU’s eudamed system and the U.S. FDA’s 510(k) registry. These registries track devices that have undergone the necessary regulatory processes for market authorization in their respective regions.

How are TeDan Surgical Innovations, Inc.’s devices classified under regulatory frameworks?

TeDan Surgical Innovations, Inc.’s devices fall into three regulatory classes: Class I (generally low-risk devices), Class II (moderate-risk devices requiring special controls), and Class IIa (a subset of Class II with specific risk profiles). The classification determines the regulatory scrutiny and authorization requirements for each device type.

What distinguishes TeDan Surgical Innovations, Inc.’s reusable surgical instruments from other manufacturers?

TeDan’s reusable instruments are designed for durability and repeated use in sterile surgical environments, which is critical for reducing waste and maintaining infection control. Their portfolio includes specialized tools like neuro retraction arms and dental drill bits, which are tailored for precision in specific procedures. The company’s focus on reusable systems also aligns with sustainability goals in healthcare.

AI-generated from registry data and not verified by a human reviewer.

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 3 of 52

Device	Model / Reference	Registries	Class	Status
Tsi	ML-0210	FDA UDI	Class I	Active
Tsi	ML-0616	FDA UDI	Class I	Active
Tsi	UL-0300	FDA UDI	Class I	Active
Tsi	MD-1468	FDA UDI	Class I	Unknown
Tsi	TK-0404	FDA UDI	Class I	Active
Stryker	48252505	FDA UDI	Class I	Unknown
Tsi	ML-0591	FDA UDI	Class I	Active
Stryker	48758462	FDA UDI	Class I	Active
Tsi	UL-0546	FDA UDI	Class I	Active
Rti	19-DILATOR-22	FDA UDI	Class I	Unknown
Tsi	HS-0242	FDA UDI	Class I	Unknown
Tsi	UL-0404	FDA UDI	Class I	Active
Zimmer	ZS-0425	FDA UDI	Class I	Active
Tsi	DS-0232	FDA UDI	Class I	Active
Tsi	CT-0112	FDA UDI	Class I	Active
Tsi	ML-0732	FDA UDI	Class I	Unknown
Stryker	48873140	FDA UDI	Class I	Active
Stryker	48852110	FDA UDI	Class I	Active
Zimmer	ZS-0460	FDA UDI	Class I	Unknown
Tsi	CS-0177	FDA UDI	Class I	Active
Tsi	CS-0083-P	FDA UDI	Class I	Active
Lattus	LAT-0063	FDA UDI	Class I	Active
Tsi	ML-0762	FDA UDI	Class I	Active
Tsi	LS-0144	FDA UDI	Class I	Active
Tsi	ML-0422	FDA UDI	Class I	Active
Tsi	TK-1132	FDA UDI	Class I	Active
Tsi	ML-0350	FDA UDI	Class I	Active
Tsi	UL-0242	FDA UDI	Class I	Active
Tsi	LS-0161	FDA UDI	Class I	Active
Tsi	LS-0163	FDA UDI	Class I	Active
Stryker	78752981	FDA UDI	Class I	Active
Tsi	CS-4099	FDA UDI	Class I	Active
Tsi	DS-0212	FDA UDI	Class I	Active
Stryker	48758455	FDA UDI	Class I	Active
Stryker	48252512	FDA UDI	Class I	Unknown
Tsi	ML-0146	FDA UDI	Class I	Active
Terumo	T400172	FDA UDI	Class I	Active
Tsi	CS-1036	FDA UDI	Class I	Active
Tsi	ML-0220	FDA UDI	Class I	Active
Stryker	48854090	FDA UDI	Class I	Active
Tsi	ML-0272	FDA UDI	Class I	Active
Stryker	48252582	FDA UDI	Class I	Active
Stryker	78752985	FDA UDI	Class I	Active
Tsi	LS-0670	FDA UDI	Class I	Active
Zimmer	ZS-0294	FDA UDI	Class I	Active
Tsi	CS-4061	FDA UDI	Class I	Active
Tsi	ML-0266	FDA UDI	Class I	Active
Tsi	LS-0051	FDA UDI	Class I	Active
Tsi	LS-0086	FDA UDI	Class I	Active
Zimmer	ZS-0226	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.

TeDan Surgical Innovations, Inc. has 13 recall records initiated between June 11, 2012, and May 15, 2020, all marked as terminated. The reasons cited include potential damage to sterile packaging that may expose products to non-sterile conditions, lack of proper pouch seals on sterile-labeled items, incorrect raw material use in production, and mechanical failures in protective packaging tubes that could compromise sterility.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

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.