STRYKER CORP.

FDA Device Registration & Listing · KALAMAZOO, MI, US · Registration 1811755

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1811755
FEI Number
1811755
Entity Name
STRYKER CORP.
City/State/Country
KALAMAZOO, MI, US
Establishment Address
4100 EAST MILHAM AVE., KALAMAZOO, MI 49001, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
STRYKER CORP. (Owner Number: 1811755)
Owner / Operator Contact Address
4100 East Milham Ave., Kalamazoo, MI 49001, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

XprESS ENT Dilation System XprESS Multi-Sinus Dilation System Cyclone Sinonasal Suction and Irrigation System XprESS Dilitation ClariFix Cryotherapy Device FoCESS HD Wireless Camera System MiniFESS Light Seeker TGS Guidewire

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2018-12-28
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2018-12-28
GBP Catheter, Multiple Lumen General, Plastic Surgery Class 1 878.4200 2018-12-28
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2018-12-28
GEH Unit, Cryosurgical, Accessories General, Plastic Surgery Class 2 878.4350 2019-11-22
FWL Camera, Cine, Endoscopic, Without Audio General, Plastic Surgery Class 1 878.4160 2018-12-28
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2019-03-19
PGW Ear, Nose, And Throat Stereotaxic Instrument Neurology Class 2 882.4560 2020-04-17

Official Correspondent

Jody Powell

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STRYKER CORP.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3003897776 BIOMIMETIC THERAPEUTICS,LLC FRANKLIN, TN, US
3040801290 Inari Medical, Costa Rica S.A. Grecia Alajuela, CR
2031049 TMJ Solutions, LLC San Buenaventura, CA, US
3016573902 Ortho-Space Ltd. Caesarea Haifa, IL
3010411911 POM Medical, LLC Moorpark, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K143738 Intuit Medical Products, LLC DSS Sinusplasty Balloon Catheter 2015-08-27
K190651 Erbe Elektromedizin GmbH ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter 2020-01-07
K760953 Spembly Medical , Ltd. DEEP FREEZE SYSTEM (DFS-30) 1976-11-16
K200041 Fiagon GmbH FlexPointer 1.5 Single Use, FlexTube 3 Single Use 2020-03-10

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2007 Stryker Instruments Div. of Stryker Corporation 2
Stryker Navigation System, eNlite System with Dell laptop computer model D800, Stryker # 7700-300-000.
Z-0006-2007 Stryker Instruments Div. of Stryker Corporation 2
Stryker Navigation System Remote Planning Stations with Dell laptop computer model D800, Stryker # 7700-010-000 and 6000-300-000.
Z-0007-2007 Stryker Instruments Div. of Stryker Corporation 2
Stryker Navigation System Dell Model D800 laptop computers (only), Stryker # 7700-309-010 and 6000-200-064.
Z-0008-2007 Stryker Instruments Div. of Stryker Corporation 2
Stryker Navigation System, Navigation Laptop System with Dell laptop computer model D800, Stryker # 6000-200-000.
Z-0020-05 Stryker Instruments, Instruments Div. 2
Stryker Navigation System - Hip Module Patient Tracker, green; Model 6007-005-000.
Z-0021-05 Stryker Instruments, Instruments Div. 2
Stryker Navigation System - Hip Module Patient Tracker, blue; Model 6007-010-000.
Z-0023-2020 Stryker Instruments Div. of Stryker Corporation 2
C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
Z-0024-2020 Stryker Instruments Div. of Stryker Corporation 2
C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
Z-0034-06 Stryker Instruments Div. of Stryker Corporation U
Stryker brand Intra-Compartmental (STIC) Pressure Monitor, Model 295-001-000.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1811755. Last updated year: 2026. Please use registration number 1811755 when referencing this establishment in official correspondence.
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