Company · US
Stryker Medical
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2023. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
10recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FPO | Stretcher, Wheeled | 5 |
| FNL | Bed, Ac-Powered Adjustable Hospital | 4 |
| HDD | Table, Obstetrical, Ac-Powered (And Accessories) | 4 |
| DWJ | System, Thermal Regulating | 3 |
| INK | Stretcher, Wheeled, Powered | 2 |
| DWI | Saw, Electrically Powered | 1 |
| FNM | Mattress, Air Flotation, Alternating Pressure | 1 |
| FQO | Table, Operating-Room, Ac-Powered | 1 |
| ILK | Transport, Patient, Powered | 1 |
| INM | Chair, With Casters | 1 |
| IOG | Treadmill, Mechanical | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 24, 2023 | K222818 | Xpedition Powered Stair Chair (625700000000) Stryker Medical | ILK |
| Aug 10, 2018 | K180834 | Altrix Precision Temperature Management System Stryker Medical | DWJ |
| Jul 18, 2017 | K171149 | Altrix Temperature Management Wraps Stryker Medical | DWJ |
| Dec 2, 2016 | K152266 | Altrix Precision Temperature Management System Stryker Medical | DWJ |
| Dec 20, 2011 | K113598 | POWER-LOAD COT FASTENER SYSTEM Stryker Medical | FPO |
| Mar 14, 1995 | K946149 | STRYKER AGILITY INTENSIVE CARE BED Stryker Medical | FNL |
| Aug 25, 1994 | K943864 | STRYKER 8000 SURGERY STRETCHER Stryker Medical | FPO |
| Jun 17, 1994 | K935949 | STRYKER 5000 Stryker Medical | FNM |
| May 6, 1994 | K941738 | STRYKER 5050 STRECHAIR Stryker Medical | INM |
| May 5, 1994 | K940068 | STRYKER OPERATING ROOM TABLE Stryker Medical | FQO |
| Feb 18, 1994 | K935297 | STRYKER AMBULANCE COT MODEL 6060 Stryker Medical | FPO |
| Sep 21, 1992 | K920526 | STRYKER DYNAMIC MATTRESS SYSTEM (DMS) MODEL #2500 Stryker Medical | IOG |
| Mar 23, 1992 | K920704 | STRYKER I.V. CADDY ACCESSORY DEVICE Stryker Medical | FPO |
| Jul 30, 1991 | K912237 | STRYKER ECLIPSE WARMING STRETCHER Stryker Medical | DWI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 31, 2006 | Stryker Medical Stryker Epic Zoom Critical Care Bed; Model 2040. Terminated |
FNL | None listed |
| Mar 31, 2006 | Stryker Medical Stryker Epic Critical Care Bed; Model 2030. Terminated |
FNL | None listed |
| May 3, 2005 | Stryker Medical Stryker brand Birthing Bed; Model 4701. Terminated |
HDD | K950889 |
| Oct 20, 2004 | Stryker Medical Stryker brand Rugged EZ-Pro R4 Ambulance Cot, model 6092. Terminated |
FPO | None listed |
| Jul 20, 2004 | Stryker Medical Stryker brand Synergy extended stay stretcher; model 1050 Terminated |
INK | None listed |
| Feb 10, 2004 | Stryker Medical Stryker brand Firstcare Ultra Maternity bed and Stryker brand Adel Maternity bed, 220 volt, model 5012, with night light. Terminated |
HDD | K950889 |
| Feb 10, 2004 | Stryker Medical Stryker brand Firstcare Ultra Maternity bed, model 5010, with night light. Terminated |
HDD | K950889 |
| Feb 10, 2004 | Stryker Medical Stryker brand Adel maternity bed, model 4700, with night light. Terminated |
HDD | K950889 |
| Dec 24, 2003 | Stryker Medical Stryker brand Model 1550 Synergy Extended Stay Stretcher Terminated |
INK | None listed |
| Jun 12, 2003 | Stryker Medical Stryker Secure II hospital bed; model 3002. Terminated |
FNL | None listed |