Stryker Medical
Portage, MI, US
STRYKER MEDICAL appears in FDA device records in Portage, MI. FDA records list 14 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 179 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Stryker Medical carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Stryker Medical Div. of Stryker Corporationrecall
- Stryker Medical Division of Stryker Corporationenforcement report, recall
510(k) clearance history
FDA records hold 14 510(k) clearances for Stryker Medical between 1991 and 2023. The busiest year on record is 1994, with 5. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 1 |
| 1992 | 2 |
| 1994 | 5 |
| 1995 | 1 |
| 2011 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K222818 | Xpedition ™ Powered Stair Chair (625700000000) | ILK | Substantially Equivalent | |
| K180834 | Altrix Precision Temperature Management System | DWJ | Substantially Equivalent | |
| K171149 | Altrix Temperature Management Wraps | DWJ | Substantially Equivalent | |
| K152266 | Altrix Precision Temperature Management System | DWJ | Substantially Equivalent | |
| K113598 | POWER-LOAD COT FASTENER SYSTEM | FPO | Substantially Equivalent | |
| K946149 | STRYKER AGILITY INTENSIVE CARE BED | FNL | Substantially Equivalent | |
| K943864 | STRYKER 8000 SURGERY STRETCHER | FPO | Substantially Equivalent | |
| K935949 | STRYKER 5000 | FNM | Substantially Equivalent | |
| K941738 | STRYKER 5050 STRECHAIR | INM | Substantially Equivalent | |
| K940068 | STRYKER OPERATING ROOM TABLE | FQO | Substantially Equivalent | |
| K935297 | STRYKER AMBULANCE COT MODEL 6060 | FPO | Substantially Equivalent | |
| K920526 | STRYKER DYNAMIC MATTRESS SYSTEM (DMS) MODEL #2500 | IOG | Substantially Equivalent | |
| K920704 | STRYKER I.V. CADDY ACCESSORY DEVICE | FPO | Substantially Equivalent | |
| K912237 | STRYKER ECLIPSE WARMING STRETCHER | DWI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1831750 | 1831750 | STRYKER MEDICAL | 3800 E. CENTRE AVE., Portage, MI 49002 US | 2026 | and 17 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- OSIBariatric Bed
- NZGBassinet, Hospital
- FNLBed, Ac-Powered Adjustable Hospital
- IOQBed, Flotation Therapy, Powered
- FNJBed, Manual
- IKZBed, Patient Rotation, Powered
- FMSBed, Pediatric Open Hospital
- FOABoard, Cardiopulmonary
- KMNChair And Table, Medical
- INNChair, Adjustable, Mechanical
- FRKChair, Examination And Treatment
- INOChair, Positioning, Electric
- INMChair, With Casters
- FMWCover, Mattress (Medical Purposes)
- KICCushion, Flotation
- FNMMattress, Air Flotation, Alternating Pressure
- IKYMattress, Flotation Therapy, Non-Powered
- KMIMonitor, Bed Patient
- FMPProtector, Skin Pressure
- DWISaw, Electrically Powered
- FOXStand, Infusion
- FZMStool, Operating-Room
- FPPStretcher, Hand-Carried
- FPOStretcher, Wheeled
- INKStretcher, Wheeled, Powered
- MSXSystem, Network And Communication, Physiological Monitors
- DWJSystem, Thermal Regulating
- HDDTable, Obstetrical, Ac-Powered (And Accessories)
- FQOTable, Operating-Room, Ac-Powered
- ILKTransport, Patient, Powered
- IOGTreadmill, Mechanical
Recall records
Showing 25 of 179| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1580-2026 | Cub Pediatric Crib, Model FL19H | Cribs sold in the USA are missing two access door warning labels. | Class II | Open, Classified | |
| Z-0919-2026 | Stryker Arise 1000EX mattress, Part Number 2236000000 | Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close proximity, suggesting a potential intent for them to be used together. These products have not been tested for compatibility and thus are not designed to be used together. The combination of both is not recommended by Stryker. | Class II | Open, Classified | |
| Z-0918-2026 | Stryker MV3 bariatric bed, Part Number 5900000001 | Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close proximity, suggesting a potential intent for them to be used together. These products have not been tested for compatibility and thus are not designed to be used together. The combination of both is not recommended by Stryker. | Class II | Open, Classified | |
| Z-0436-2024 | ProCurity bed series, model number 3009, item number: 3009PX-ZX-450. | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. | Class II | Open, Classified | |
| Z-0435-2024 | ProCurity bed series, model number 3009, item number: 3009PX-ZMX-600. | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. | Class II | Open, Classified | |
| Z-0434-2024 | ProCurity bed series, model number 3009, item number: 3009PX-ZMX-450. | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. | Class II | Open, Classified | |
| Z-0433-2024 | ProCuity bed series, model number 3009, item number: 3009PX-ZM-600. | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. | Class II | Open, Classified | |
| Z-0432-2024 | ProCuity bed series, model number 3009, item number: 3009PX-ZM-450. | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. | Class II | Open, Classified | |
| Z-0431-2024 | ProCuity bed series, model number 3009, item number: 3009PX-Z-450. | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. | Class II | Open, Classified | |
| Z-0430-2024 | ProCuity bed series, model number 3009, item number: 3009PX-LEX-450. | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. | Class II | Open, Classified | |
| Z-0429-2024 | ProCuity bed series, model number 3009, item number: 3009PX-LEX-400. | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. | Class II | Open, Classified | |
| Z-0428-2024 | ProCuity bed series, model number 3009, item number: 3009PX-LE-450. | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. | Class II | Open, Classified | |
| Z-0427-2024 | ProCuity bed series, model number 3009, item number: 3009PX-LE-400. | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. | Class II | Open, Classified | |
| Z-0426-2024 | ProCuity bed series, model number 3009, item number: 3009PX-L-200 | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. | Class II | Open, Classified | |
| Z-0425-2024 | ProCuity bed series, model number 3009, item number: 3009PX-L-100. | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. | Class II | Open, Classified | |
| Z-0424-2024 | ProCuity bed series, model number 3009, item number: 300900000000, | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. | Class II | Open, Classified | |
| Z-2130-2023 | Power-PRO 2- A powered ambulance cot that consists of a platform, including a mattress, mounted on a wheeled, retractable X-frame that is designed to support and transport a maximum weight of 700 lb (318 kg). Model Number: 6507 | Base leg assembly may bend and result in difficulty engaging/disengaging from fastener, difficulty loading/unloading from ambulance, difficulty raising or lowering the cot, cot tip, or erratic or unintended motion. | Class II | Open, Classified | |
| Z-1256-2023 | Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency location. Model: 650705550001 | Transport Cot has insufficient volume of epoxy to assemblies installed in the head section and foot sectioning system may result in separation of head end or foot end from the cot and result in unexpected disengagement while loading/unloading or transport. | Class II | Open, Classified | |
| Z-0479-2023 | Power-PRO 2, Model No. 6507, Item No. 650705550001 (US); 650700000000 (International) | Cot may experience unintended motion due to damaged cables. Potential risk of soft tissue injury to patients such as scrapes or bruises resulting from the cot lowering faster than expected. | Class II | Open, Classified | |
| Z-2223-2021 | GoBed II MedSurg Bed, Model Number FL28, Part #FL28EX | Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals | Class II | Open, Classified | |
| Z-2222-2021 | Electric MedSurg Bed FL23 - AC-powered adjustable hospital bed with four built-in electric DC motors and remote controls that is intended for medical purposes, Model Number: FL23, Part #FL23SE | Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals | Class II | Open, Classified | |
| Z-2221-2021 | CUB Pediatric Crib- intended to provide a pediatric patient support surface for medical purposes and to provide a method of transporting pediatric patients within a healthcare facility Model Number: FL19 Part #5050000000 | Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals | Class II | Open, Classified | |
| Z-2220-2021 | Stretcher Chair-for use in all acute care hospitals and medical outpatient services Model Number: 5050 Part # 5050000000 | Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals | Class II | Open, Classified | |
| Z-2219-2021 | Michael Graves with Stryker Highback Chair-intended for pediatric and adult person guest and patient seating use in an indoor medical setting, Model Number 4853, Part #4853000000 | Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals | Class II | Open, Classified | |
| Z-2218-2021 | Symmetry Plus Treatment Recliner - general hospital use as a convenient seating surface for patients or guests to sit, Model Number 3500, Part # 3500000710 | Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain