FDA Registration Active 🇺🇸 United States

STRYKER MEDICAL

Reg #: 1831750 · FEI: 1831750 · Expires 2026
Products
27
Proprietary Names
97
Establishment Types
3
Classifications
27

Registration Details

Registration Name
STRYKER MEDICAL
Registration Number
1831750
FEI Number
1831750
Status
Active
Expiry Year
2026
Initial Importer
No
Address
3800 E. CENTRE AVE.
City
Portage
State
MI
ZIP
49002
Country
US

Regulatory Submissions

510(k) Number
K103536

Owner / Operator

Firm Name
STRYKER CORP.
Operator Number
1811755
Address
4100 East Milham Ave.
City
Kalamazoo
State
MI
Postal Code
49001
Country
US

Products

Device Name Product Code
Chair, Adjustable, Mechanical INN
Cover, Mattress (Medical Purposes) FMW
Bed, Ac-Powered Adjustable Hospital FNL
Protector, Skin Pressure FMP
Stretcher, Wheeled FPO
Chair, Examination And Treatment FRK
Stretcher, Wheeled, Powered INK
Bed, Pediatric Open Hospital FMS
Bed, Flotation Therapy, Powered IOQ
Bariatric Bed OSI
Monitor, Bed Patient KMI
Transport, Patient, Powered ILK
Table, Obstetrical, Ac-Powered (And Accessories) HDD
System, Network And Communication, Physiological Monitors MSX
Bed, Patient Rotation, Powered IKZ
Cushion, Flotation KIC
Chair, Positioning, Electric INO
Stand, Infusion FOX
Bassinet, Hospital NZG
Bed, Manual FNJ
Stretcher, Hand-Carried FPP
Stool, Operating-Room FZM
Board, Cardiopulmonary FOA
Mattress, Air Flotation, Alternating Pressure FNM
Chair, With Casters INM
Chair And Table, Medical KMN
Mattress, Flotation Therapy, Non-Powered IKY

Proprietary Names

Prime TC with Swing Away Prime TC IsoFlex Mattress Cover XPRT Mattress Cover CHG Prevention Surface Cover iBed Wireless with iBed awareness S3 MEDSURG BED w/ iBED WIRELESS, BED EXTENDER (ACCESSORY), MATTRESS EXTENDER (ACCESSORY), IV POLE (ACCESSORY) InTouch with iBed Wireless Leg Positioner Disposables SofCare Heel Care Boot MX-Pro Ambulance Cot Restraint straps (accessory) Stryker Eye Stretcher Chair Stryker Eye Surgery Stretcher "Gynnie" ObGyn Stretcher PowerPRO TL Ambulance Cot Stryker Fluoroscopy Stretcher PowerPRO Ambulance Cot Prime Series 5th Wheel Stretcher Stryker Stretcher Chair Stryker Trauma Stretcher Stryker Transport Stretcher M1 Roll-In System PerformancePRO-XT PowerPro-XT Prime Series Big Wheel Stretcher Performance-LOAD PerformancePRO Stryker Cot Fastener Arm board (Accessory) Stretcher Extender (Accessory) Pre-Op/Post-Op Head Extension (Accessory) X-Ray Cassette Holder (Accessory) HAVASU IV Pole (Accessory) Power-PRO 2 Prime X Prime Connect PowerPRO IT Ambulance Cot TREATMENT RECLINER Symmetry Plus Narrow Treatment Recliner Symnmetry Plus Treatment Recliner Prime X Zoom Prime Series Big Wheel Zoom Stretcher Prime Zoom Stretcher Restraint Strap (Accessory) CUB Sofcare Plus SPR Plus II Duogard Sofcare Companion Pump IsoFlex LAL AIR+ Pump SofCare manual handpump MV3 Bariatric Bed, Patient Helper (Accessory), IV Pole (Accessory) Xpedition Model 4701 Maternity Bed LD304 Birthing Bed Engage Medical Device Alarm Notification System Isolibrium Isolibrium PE Support Surface SofCare Chair Cushion (Bariatric) SofCare Chair Cushion Tru-Rize IV Pole THC5 Stand TPS2 Stand Infusion Stand MS -00017 MOLLI Pole Clamp Hydro Pole Mount Nara Platform Bed GOBED II MED/SURG BED S3 MEDSURG BED, BED EXTENDER (ACCESSORY), MATTRESS EXTENDER (ACCESSORY), IV POLE (ACCESSORY) EPIC II CRITICAL CARE BED INTOUCH CRITICAL CARE BED PROCUITY BED, BED EXTENDER (ACCESSORY), MATTRESS EXTENDER (ACCESSORY), SECURE CONNECT (ACCESSORY) Rugged Transfer Flat RUGGED STAIR-PRO Evac Chair PowerLOAD Surgi-Stool II CHG CPR Board IsoTour mattress, Isotour pump (accessory), mattress extender (accessory), turn assist upgrade kit (accessory) IsoAir Patient Chair Michael Graves with Stryker Patient Chair- Highback, Comfort-Flex, Lowback, armless ComfortGel Pioneer Stretcher Mattress Ultra Comfort Mattress Enhanced Comfort Mattress ProForm Ultra ComfortSE ComfortGel SE IsoFlex SE IsoTour , mattress extender (accessory), turn assist upgrade kit (accessory) Non-Powered Bariatric Support Surface

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility