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XODUS MEDICAL, INC.

United States·US-MF-000003939

Last updated September 17, 2026

What XODUS MEDICAL, INC. makes

Xodus Medical, Inc. manufactures single-use procedural medication labeling sets, operating table patient positioning sets, freestanding patient positioners, monopolar electrosurgical electrodes for open surgery, sharp surgical instrument counting trays or pads, skin marking pens, operating room turnover kits, and reusable operating table patient pressure distribution pads.

The company's devices are classified as Class I and Class II medical devices and are listed in the FDA's Unique Device Identification (fda_udi) registry. Xodus Medical, Inc. 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 Xodus Medical, Inc. manufacture?

Xodus Medical, Inc. manufactures procedural medication labeling sets, operating table patient positioning sets, freestanding patient positioners, monopolar electrosurgical electrodes for open surgery, sharp surgical instrument counting trays or pads, skin marking pens, operating room turnover kits, and reusable operating table patient pressure distribution pads. These products are designed for single-use or reusable applications in surgical and procedural settings, as specified in the device data.

Where is Xodus Medical, Inc. based?

Xodus Medical, Inc. is based in the United States, as explicitly stated in the device data under the COUNTRY field and confirmed in the SUMMARY section, which notes the company's location without referencing any specific city, state, or facility details beyond the country level.

In which regulatory registry are Xodus Medical, Inc.'s devices listed?

Xodus Medical, Inc.'s devices are listed in the FDA's Unique Device Identification (fda_udi) registry, as indicated in the LISTED IN field and reiterated in the SUMMARY, which confirms the company's devices are included in this specific U.S. regulatory system for device tracking and identification.

How are Xodus Medical, Inc.'s devices classified under regulatory frameworks?

Xodus Medical, Inc.'s devices are classified as Class I and Class II medical devices, according to the DEVICE CLASSES field in the provided data. This classification reflects the risk-based regulatory categorization used by the FDA, where Class I devices are low-risk and Class II devices require special controls, but neither classification implies approval or clearance of the company itself.

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

Information

Country
United States
Address
702, Prominence Drive, New Kensington, United States
Website
www.xodusmedical.com
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
7243375500
PRRC Contact
Paul Lloyd
EUDAMED SRN
US-MF-000003939
FDA FEI Number
1000221205
DUNS Number
868042664

Catalogue (3442)

Page 5 of 69
DeviceModel / ReferenceRegistriesClassStatus
SPK10243 AB Jackson Table Kit - Male SPK10243
FDA UDI
Class IActive
SPK10927 Surgical BackPack Kit SPK10927
FDA UDI
Class IActive
CL24541 Custom Med Label Pack CL24541
FDA UDI
Class IActive
NSCL20826 Custom Med Label Pack NSCL20826
FDA UDI
Class IActive
CL20781 Custom Med Label Pack CL20781
FDA UDI
Class IActive
CL22340 Custom Med Label Pack CL22340
FDA UDI
Class IActive
NSCL20340 Custom Med Label Pack NSCL20340
FDA UDI
Class IActive
SPK10185 Jackson Table Kit SPK10185
FDA UDI
Class IActive
NSCL22259 Custom Med Label Pack NSCL22259
FDA UDI
Class IActive
NSCL21235 Custom Med Label Pack NSCL21235
FDA UDI
Class IActive
CL21525 Custom Med Label Pack CL21525
FDA UDI
Class IActive
NS70930 Needle Counter Double Blank Magnet Small NS70930
FDA UDI
Class IActive
40782 PinkProtect - Positioning Kit for the ICU 40782
FDA UDI
Class IActive
CL22387 Custom Med Label Pack CL22387
FDA UDI
Class IActive
CL21693 Custom Med Label Pack CL21693
FDA UDI
Class IActive
6.5" Blade Tip Extended Insulation; Blue PTFE; Blue Insulation; NS20015
FDA UDI
Class IIActive
70861 Needle Counter 30 Count Magnet w/ Clear Top 70861
FDA UDI
Class IActive
RTK10291 Room Turnover Kit RTK10291
FDA UDI
Class IActive
CL22313 Custom Med Label Pack CL22313
FDA UDI
Class IActive
NSCL22260 Custom Med Label Pack NSCL22260
FDA UDI
Class IActive
CL22759 Custom Med Label Pack CL22759
FDA UDI
Class IActive
SPK10032 Jackson Table Positioning Kit SPK10032
FDA UDI
Class IActive
41870 Chest Positioner (Left) 41870
FDA UDI
Class IActive
SPK10259 Jackson Kit SPK10259
FDA UDI
Class IActive
SPK10227 Jackson Table Kit SPK10227
FDA UDI
Class IActive
NSCL22610 Custom Med Label Pack NSCL22610
FDA UDI
Class IActive
NSCL21828 Custom Med Label Pack NSCL21828
FDA UDI
Class IActive
SPK10572 Wilson Table Kit SPK10572
FDA UDI
Class IActive
40640 Reverse Trendelenberg Positioning Kit 40640
FDA UDI
Class IActive
SPK10381 Wilson Kit SPK10381
FDA UDI
Class IActive
NSCL22734 Custom Med Label Pack NSCL22734
FDA UDI
Class IActive
NSCL24613 Custom Med Label Pack NSCL24613
FDA UDI
Class IActive
NSCL22266 Custom Med Label Pack NSCL22266
FDA UDI
Class IActive
NS10407 Permanent Marker; Round Pen Regular Tip; w/ Ruler and Labels NS10407
FDA UDI
Class IActive
SPK10187 Wilson Table Kit SPK10187
FDA UDI
Class IActive
CL24236 Custom Med Label Pack CL24236
FDA UDI
Class IActive
CL22227 Custom Med Label Pack CL22227
FDA UDI
Class IActive
CL20789 Custom Med Label Pack CL20789
FDA UDI
Class IActive
NSCL24238 Custom Med Label Pack NSCL24238
FDA UDI
Class IActive
SPK11025 Surgical BackPack Kit SPK11025
FDA UDI
Class IActive
CL21333 Custom Med Label Pack CL21333
FDA UDI
Class IActive
NSCL22319 Custom Med Label Pack NSCL22319
FDA UDI
Class IActive
NSCL23543 Custom Med Label Pack NSCL23543
FDA UDI
Class IActive
CL24492 Custom Med Label Pack CL24492
FDA UDI
Class IActive
RTK10167 Room Turnover Kit RTK10167
FDA UDI
Class IActive
33cm Laparoscopic Round Spatula; Blue PTFE; Black Insulation; PL 20144ACT
FDA UDI
Class IIActive
SPK11246 Andrew Kit SPK11246
FDA UDI
Class IActive
NS80730CARD Single Use Magnetic Transfer Zone 3" x 4.5" NS80730CARD
FDA UDI
Class IActive
NSCL22099 Custom Med Label Pack NSCL22099
FDA UDI
Class IActive
CL23762 Custom Med Label Pack CL23762
FDA UDI
Class IActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (3)

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

The FDA recall records for Xodus Medical, Inc. show 3 recall records. The earliest and most recent recall records were both initiated on 2019-09-19. All recalls have a status of terminated. The reasons given for the recalls include that the sterile barrier of some devices may have been affected.

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

DateRecall No.ClassStatusReason
Sep 19, 2019Z-0150-2020—terminated

The sterile barrier of some devices may have been affected

Sep 19, 2019Z-0151-2020—terminated

The sterile barrier of some devices may have been affected

Sep 19, 2019Z-0149-2020—terminated

The sterile barrier of some devices may have been affected