ClearanceBrief
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

CodeDeviceRecords
FNLBed, Ac-Powered Adjustable Hospital40
FPOStretcher, Wheeled19
INKStretcher, Wheeled, Powered9
IKYMattress, Flotation Therapy, Non-Powered5
DWJSystem, Thermal Regulating4
ILKTransport, Patient, Powered4
FPPStretcher, Hand-Carried3
FMSBed, Pediatric Open Hospital2
FNMMattress, Air Flotation, Alternating Pressure2
IOQBed, Flotation Therapy, Powered2
KMNChair And Table, Medical2
FOXStand, Infusion1
FRKChair, Examination And Treatment1
FZMStool, Operating-Room1
IKZBed, Patient Rotation, Powered1
ILOPack, Hot Or Cold, Water Circulating1
INNChair, Adjustable, Mechanical1
INOChair, Positioning, Electric1
NZGBassinet, Hospital1
OSIBariatric Bed1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Mar 19, 2026Stryker Medical Division of Stryker Corporation
Cub Pediatric Crib, Model FL19H
Open, Classified
FMSNone listed
Dec 11, 2025Stryker Medical Division of Stryker Corporation
Stryker Arise 1000EX mattress, Part Number 2236000000
Open, Classified
FNMNone listed
Dec 11, 2025Stryker Medical Division of Stryker Corporation
Stryker MV3 bariatric bed, Part Number 5900000001
Open, Classified
OSINone listed
Dec 1, 2023Stryker Medical Division of Stryker Corporation
ProCurity bed series, model number 3009, item number: 3009PX-ZX-450.
Open, Classified
FNLNone listed
Dec 1, 2023Stryker Medical Division of Stryker Corporation
ProCurity bed series, model number 3009, item number: 3009PX-ZMX-600.
Open, Classified
FNLNone listed
Dec 1, 2023Stryker Medical Division of Stryker Corporation
ProCurity bed series, model number 3009, item number: 3009PX-ZMX-450.
Open, Classified
FNLNone listed
Dec 1, 2023Stryker Medical Division of Stryker Corporation
ProCuity bed series, model number 3009, item number: 3009PX-ZM-600.
Open, Classified
FNLNone listed
Dec 1, 2023Stryker Medical Division of Stryker Corporation
ProCuity bed series, model number 3009, item number: 3009PX-ZM-450.
Open, Classified
FNLNone listed
Dec 1, 2023Stryker Medical Division of Stryker Corporation
ProCuity bed series, model number 3009, item number: 3009PX-Z-450.
Open, Classified
FNLNone listed
Dec 1, 2023Stryker Medical Division of Stryker Corporation
ProCuity bed series, model number 3009, item number: 3009PX-LEX-450.
Open, Classified
FNLNone listed
Dec 1, 2023Stryker Medical Division of Stryker Corporation
ProCuity bed series, model number 3009, item number: 3009PX-LEX-400.
Open, Classified
FNLNone listed
Dec 1, 2023Stryker Medical Division of Stryker Corporation
ProCuity bed series, model number 3009, item number: 3009PX-LE-450.
Open, Classified
FNLNone listed
Dec 1, 2023Stryker Medical Division of Stryker Corporation
ProCuity bed series, model number 3009, item number: 3009PX-LE-400.
Open, Classified
FNLNone listed
Dec 1, 2023Stryker Medical Division of Stryker Corporation
ProCuity bed series, model number 3009, item number: 3009PX-L-200
Open, Classified
FNLNone listed
Dec 1, 2023Stryker Medical Division of Stryker Corporation
ProCuity bed series, model number 3009, item number: 3009PX-L-100.
Open, Classified
FNLNone listed
Dec 1, 2023Stryker Medical Division of Stryker Corporation
ProCuity bed series, model number 3009, item number: 300900000000,
Open, Classified
FNLNone listed
Jul 12, 2023Stryker 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
FPONone listed
Mar 15, 2023Stryker 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
FPONone listed
Dec 14, 2022Stryker Medical Division of Stryker Corporation
Power-PRO 2, Model No. 6507, Item No. 650705550001 (US); 650700000000 (International)
Open, Classified
FPONone listed
May 12, 2021Stryker Medical Division of Stryker Corporation
GoBed II MedSurg Bed, Model Number FL28, Part #FL28EX
Open, Classified
FNLNone listed
May 12, 2021Stryker 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
FNLNone listed
May 12, 2021Stryker 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
FMSNone listed
May 12, 2021Stryker 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
KMNNone listed
May 12, 2021Stryker 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
KMNNone listed
May 12, 2021Stryker 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
FRKNone listed
May 12, 2021Stryker 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
INONone listed
May 12, 2021Stryker 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
FNLNone listed
May 12, 2021Stryker 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
IKZNone listed
May 12, 2021Stryker 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
FNLNone listed
May 12, 2021Stryker 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
IKYNone listed
May 12, 2021Stryker 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
IKYNone listed
May 12, 2021Stryker 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
IKYNone listed
May 12, 2021Stryker 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
FNLNone listed
May 12, 2021Stryker 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
INNNone listed
May 12, 2021Stryker 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
FPONone listed
May 12, 2021Stryker 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
FPONone listed
May 12, 2021Stryker Medical Division of Stryker Corporation
Surgistool-intended to support a healthcare professional during surgical procedures Model 830, Part Number 0830000000
Open, Classified
FZMNone listed
May 12, 2021Stryker 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
FPONone listed
Aug 12, 2020Stryker 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
IKYNone listed
Apr 7, 2020Stryker 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
INKNone listed
May 15, 2019Stryker Medical Division of Stryker Corporation
Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000
Terminated
FPOK113598
Feb 7, 2019Stryker Medical Division of Stryker Corporation
Naera Hospital Bassinet, Model No. 4402
Terminated
NZGNone listed
Oct 8, 2018Stryker Medical Division of Stryker Corporation
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
Terminated
FNLNone listed
Oct 8, 2018Stryker Medical Division of Stryker Corporation
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
Terminated
FNLNone listed
Sep 6, 2018Stryker 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
DWJK152266
K180834
Aug 13, 2018Stryker 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
IOQNone listed
May 1, 2018Stryker 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
FPOK113598
Mar 14, 2018Stryker Medical Division of Stryker Corporation
T/Pump temperature therapy pump, Models TP700 and TP700C
Terminated
ILOK073675
Mar 9, 2018Stryker Medical Division of Stryker Corporation
6381 M-1 Cot Fastener, catalog no. 6381000000
Terminated
FPONone listed
Mar 9, 2018Stryker Medical Division of Stryker Corporation
6376 M-1 Cot Fastener, catalog no. 6376000000
Terminated
FPONone listed

Newest 50 of 101.

Get alerts for these product codes