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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Chair, Adjustable, Mechanical | INN | Class 1 | Physical Medicine | No | 2013-09-13 |
| Cover, Mattress (Medical Purposes) | FMW | Class 1 | General Hospital | No | 1994-09-21 |
| Bed, Ac-Powered Adjustable Hospital | FNL | Class 2 | General Hospital | No | 2010-12-27 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 1977-12-29 |
| Stretcher, Wheeled | FPO | Class 2 | General Hospital | No | 1992-12-15 |
| Chair, Examination And Treatment | FRK | Class 1 | General Hospital | No | 2003-04-14 |
| Stretcher, Wheeled, Powered | INK | Class 2 | Physical Medicine | No | 2014-06-03 |
| Bed, Pediatric Open Hospital | FMS | Class 2 | General Hospital | No | 2001-08-08 |
| Bed, Flotation Therapy, Powered | IOQ | Class 2 | Physical Medicine | No | 1992-12-15 |
| Bariatric Bed | OSI | Class 2 | General Hospital | No | 2019-07-09 |
| Monitor, Bed Patient | KMI | Class 1 | General Hospital | No | 2018-06-14 |
| Transport, Patient, Powered | ILK | Class 2 | Physical Medicine | No | 2023-04-10 |
| Table, Obstetrical, Ac-Powered (And Accessories) | HDD | Class 2 | Obstetrics/Gynecology | No | 2008-03-31 |
| System, Network And Communication, Physiological Monitors | MSX | Class 2 | Cardiovascular | No | 2022-06-07 |
| Bed, Patient Rotation, Powered | IKZ | Class 2 | Physical Medicine | No | 2006-11-30 |
| Cushion, Flotation | KIC | Class 1 | Physical Medicine | No | 2010-11-02 |
| Chair, Positioning, Electric | INO | Class 2 | Physical Medicine | No | 2016-06-13 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 1992-12-15 |
| Bassinet, Hospital | NZG | Class 2 | General Hospital | No | 2015-05-11 |
| Bed, Manual | FNJ | Class 1 | General Hospital | No | 1999-09-21 |
| Stretcher, Hand-Carried | FPP | Class 1 | General Hospital | No | 2002-09-16 |
| Stool, Operating-Room | FZM | Class 1 | General, Plastic Surgery | No | 1992-12-15 |
| Board, Cardiopulmonary | FOA | Class 1 | General Hospital | No | 2015-01-29 |
| Mattress, Air Flotation, Alternating Pressure | FNM | Class 2 | General Hospital | No | 1992-12-15 |
| Chair, With Casters | INM | Class 1 | Physical Medicine | No | 2010-04-29 |
| Chair And Table, Medical | KMN | Class 1 | General Hospital | No | 2010-09-07 |
| Mattress, Flotation Therapy, Non-Powered | IKY | Class 1 | General Hospital | No | 1992-12-15 |
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