Company
Stryker Medical Division of Stryker Corporation
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
101recalls (3 in 12 months)
10recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FNL | Bed, Ac-Powered Adjustable Hospital | 40 |
| FPO | Stretcher, Wheeled | 19 |
| INK | Stretcher, Wheeled, Powered | 9 |
| IKY | Mattress, Flotation Therapy, Non-Powered | 5 |
| DWJ | System, Thermal Regulating | 4 |
| ILK | Transport, Patient, Powered | 4 |
| FPP | Stretcher, Hand-Carried | 3 |
| FMS | Bed, Pediatric Open Hospital | 2 |
| FNM | Mattress, Air Flotation, Alternating Pressure | 2 |
| IOQ | Bed, Flotation Therapy, Powered | 2 |
| KMN | Chair And Table, Medical | 2 |
| FOX | Stand, Infusion | 1 |
| FRK | Chair, Examination And Treatment | 1 |
| FZM | Stool, Operating-Room | 1 |
| IKZ | Bed, Patient Rotation, Powered | 1 |
| ILO | Pack, Hot Or Cold, Water Circulating | 1 |
| INN | Chair, Adjustable, Mechanical | 1 |
| INO | Chair, Positioning, Electric | 1 |
| NZG | Bassinet, Hospital | 1 |
| OSI | Bariatric Bed | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 19, 2026 | Stryker Medical Division of Stryker Corporation Cub Pediatric Crib, Model FL19H Open, Classified |
FMS | None listed |
| Dec 11, 2025 | Stryker Medical Division of Stryker Corporation Stryker Arise 1000EX mattress, Part Number 2236000000 Open, Classified |
FNM | None listed |
| Dec 11, 2025 | Stryker Medical Division of Stryker Corporation Stryker MV3 bariatric bed, Part Number 5900000001 Open, Classified |
OSI | None listed |
| Dec 1, 2023 | Stryker Medical Division of Stryker Corporation ProCurity bed series, model number 3009, item number: 3009PX-ZX-450. Open, Classified |
FNL | None listed |
| Dec 1, 2023 | Stryker Medical Division of Stryker Corporation ProCurity bed series, model number 3009, item number: 3009PX-ZMX-600. Open, Classified |
FNL | None listed |
| Dec 1, 2023 | Stryker Medical Division of Stryker Corporation ProCurity bed series, model number 3009, item number: 3009PX-ZMX-450. Open, Classified |
FNL | None listed |
| Dec 1, 2023 | Stryker Medical Division of Stryker Corporation ProCuity bed series, model number 3009, item number: 3009PX-ZM-600. Open, Classified |
FNL | None listed |
| Dec 1, 2023 | Stryker Medical Division of Stryker Corporation ProCuity bed series, model number 3009, item number: 3009PX-ZM-450. Open, Classified |
FNL | None listed |
| Dec 1, 2023 | Stryker Medical Division of Stryker Corporation ProCuity bed series, model number 3009, item number: 3009PX-Z-450. Open, Classified |
FNL | None listed |
| Dec 1, 2023 | Stryker Medical Division of Stryker Corporation ProCuity bed series, model number 3009, item number: 3009PX-LEX-450. Open, Classified |
FNL | None listed |
| Dec 1, 2023 | Stryker Medical Division of Stryker Corporation ProCuity bed series, model number 3009, item number: 3009PX-LEX-400. Open, Classified |
FNL | None listed |
| Dec 1, 2023 | Stryker Medical Division of Stryker Corporation ProCuity bed series, model number 3009, item number: 3009PX-LE-450. Open, Classified |
FNL | None listed |
| Dec 1, 2023 | Stryker Medical Division of Stryker Corporation ProCuity bed series, model number 3009, item number: 3009PX-LE-400. Open, Classified |
FNL | None listed |
| Dec 1, 2023 | Stryker Medical Division of Stryker Corporation ProCuity bed series, model number 3009, item number: 3009PX-L-200 Open, Classified |
FNL | None listed |
| Dec 1, 2023 | Stryker Medical Division of Stryker Corporation ProCuity bed series, model number 3009, item number: 3009PX-L-100. Open, Classified |
FNL | None listed |
| Dec 1, 2023 | Stryker Medical Division of Stryker Corporation ProCuity bed series, model number 3009, item number: 300900000000, Open, Classified |
FNL | None listed |
| Jul 12, 2023 | Stryker Medical Division of Stryker Corporation 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 ( Open, Classified |
FPO | None listed |
| Mar 15, 2023 | Stryker Medical Division of Stryker Corporation Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency location.
Model: 650705550001 Open, Classified |
FPO | None listed |
| Dec 14, 2022 | Stryker Medical Division of Stryker Corporation Power-PRO 2, Model No. 6507, Item No. 650705550001 (US); 650700000000 (International) Open, Classified |
FPO | None listed |
| May 12, 2021 | Stryker Medical Division of Stryker Corporation GoBed II MedSurg Bed, Model Number FL28, Part #FL28EX Open, Classified |
FNL | None listed |
| May 12, 2021 | Stryker Medical Division of Stryker Corporation 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 Open, Classified |
FNL | None listed |
| May 12, 2021 | Stryker Medical Division of Stryker Corporation 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: Open, Classified |
FMS | None listed |
| May 12, 2021 | Stryker Medical Division of Stryker Corporation Stretcher Chair-for use in all acute care hospitals and medical outpatient services
Model Number: 5050
Part # 5050000000 Open, Classified |
KMN | None listed |
| May 12, 2021 | Stryker Medical Division of Stryker Corporation 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 Open, Classified |
KMN | None listed |
| May 12, 2021 | Stryker Medical Division of Stryker Corporation Symmetry Plus Treatment Recliner - general hospital use as a convenient seating surface for patients or guests to sit, Model Number 3500, Part # 3500000710 Open, Classified |
FRK | None listed |
| May 12, 2021 | Stryker Medical Division of Stryker Corporation TruRize Clinical Chair - support structure that places human occupants in upright, seated, recline, supine, and trend positions, Model Number: 3333, Part #3333000000 Open, Classified |
INO | None listed |
| May 12, 2021 | Stryker Medical Division of Stryker Corporation S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number: 3005, Part # 3005S3EX Open, Classified |
FNL | None listed |
| May 12, 2021 | Stryker Medical Division of Stryker Corporation Isolibrium Support Surface - support surface assists in the prevention and treatment of all pressure injury stages (including stages 1, 2, 3, 4, Unstageable and Deep Tissue Pressure Injury, Model Numb Open, Classified |
IKZ | None listed |
| May 12, 2021 | Stryker Medical Division of Stryker Corporation S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number 3002, Part 3002S3CUSTOM, 3002S3EX, 3002S3PATRIOT Open, Classified |
FNL | None listed |
| May 12, 2021 | Stryker Medical Division of Stryker Corporation IsoGel Air - support surface assists in the prevention and treatment of all pressure ulcers stages, Model Number 2860, Part 2860000999 Open, Classified |
IKY | None listed |
| May 12, 2021 | Stryker Medical Division of Stryker Corporation ComfortGel - assists in the prevention and treatment of all pressure injury stages, Model Number 2850, Part # 2850000999, 2850000001, 2850000009 Open, Classified |
IKY | None listed |
| May 12, 2021 | Stryker Medical Division of Stryker Corporation Proform- support surface is used to assist in the prevention and treatment of all categories/stages of pressure ulcers, Model Number: 2710, Part #2710000027 Open, Classified |
IKY | None listed |
| May 12, 2021 | Stryker Medical Division of Stryker Corporation InTouch 2131-intended to support a human patient in an acute care setting, Model Number: 2131000000, Part #1460000000 Open, Classified |
FNL | None listed |
| May 12, 2021 | Stryker Medical Division of Stryker Corporation Prime TC-transport chair intended for medical purposes to assist a person in performing an activity that the person would find difficult to do or be unable to do
Model Number: 1460, Part #1460000000 Open, Classified |
INN | None listed |
| May 12, 2021 | Stryker Medical Division of Stryker Corporation Prime Big Wheel Stretcher-used as a short-term outpatient clinical evaluation, treatment, minor procedure, and short-term outpatient recovery platform, Model Number 1115, Part Number 1115000030 Open, Classified |
FPO | None listed |
| May 12, 2021 | Stryker Medical Division of Stryker Corporation Prime Fifth Wheel Stretcher-stretcher may be used for minor procedures and short-term stay (treatment and recovery, Model 1105, Part Numbers 1105000026 and 1105000000X Open, Classified |
FPO | None listed |
| May 12, 2021 | Stryker Medical Division of Stryker Corporation Surgistool-intended to support a healthcare professional during surgical procedures
Model 830, Part Number 0830000000 Open, Classified |
FZM | None listed |
| May 12, 2021 | Stryker Medical Division of Stryker Corporation Transport Stretcher 747 - a non-powered, wheeled device designed to support patients in a horizontal position, Part Number 0747000000 Open, Classified |
FPO | None listed |
| Aug 12, 2020 | Stryker Medical Division of Stryker Corporation Stryker IsoAir 2.0 support surface-provides pressure redistribution and is intended to assist in management of the microclimate of the patient skin, Model Number: 2941-001-100 Terminated |
IKY | None listed |
| Apr 7, 2020 | Stryker Medical Division of Stryker Corporation Stryker Power-PRO TL cot-powered ambulance cot
Model Number 6550 - Product Usage: is a powered wheeled stretcher that is intended to support and transport the entire body of a traumatized, ambulator Terminated |
INK | None listed |
| May 15, 2019 | Stryker Medical Division of Stryker Corporation Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000 Terminated |
FPO | K113598 |
| Feb 7, 2019 | Stryker Medical Division of Stryker Corporation Naera Hospital Bassinet, Model No. 4402 Terminated |
NZG | None listed |
| Oct 8, 2018 | Stryker Medical Division of Stryker Corporation The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option Terminated |
FNL | None listed |
| Oct 8, 2018 | Stryker Medical Division of Stryker Corporation The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option Terminated |
FNL | None listed |
| Sep 6, 2018 | Stryker Medical Division of Stryker Corporation Altrix Precision Temperature Management System
Model: 8001Product Usage:
The Altrix system is intended for circulating temperature controlled warm or cold water via patient contact thermal transfer de Terminated |
DWJ | K152266 K180834 |
| Aug 13, 2018 | Stryker Medical Division of Stryker Corporation IsoFlex LAL Support Surface, Model Number 2860
Product Usage:
:
The IsoFlex LAL support surface assists in the prevention and treatment of all pressure injuries (including stages 1,2,3,4, unstageab Terminated |
IOQ | None listed |
| May 1, 2018 | Stryker Medical Division of Stryker Corporation Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000, UDI: 07613327261523
Power-LOAD is intended to assist with loading and unloading of a compatible wheeled stretcher (ambulance cot) Terminated |
FPO | K113598 |
| Mar 14, 2018 | Stryker Medical Division of Stryker Corporation T/Pump temperature therapy pump, Models TP700 and TP700C Terminated |
ILO | K073675 |
| Mar 9, 2018 | Stryker Medical Division of Stryker Corporation 6381 M-1 Cot Fastener, catalog no. 6381000000 Terminated |
FPO | None listed |
| Mar 9, 2018 | Stryker Medical Division of Stryker Corporation 6376 M-1 Cot Fastener, catalog no. 6376000000 Terminated |
FPO | None listed |
Newest 50 of 101.