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Stryker Corporation FDA Approvals
0 new drug approvals and 11 device clearances on file. Matched by name to SYK.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control510(k)Aug 18, 2023Gastroenterology, Urology |
| Sonopet 1Q 3 7cm 1Q Large510(k)Feb 16, 2023 |
| Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System510(k)Feb 16, 2023Neurology |
| Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran Anterior Cervical Plating (ACP) System, Reflex Hybrid ACP System, UniVise Spinous Process Fixation Plate510(k)Oct 19, 2022Orthopedic |
| OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device510(k)Sep 16, 2022General, Plastic Surgery |
| Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit510(k)Jul 12, 2022Neurology |
| Sonopet iQ Ultrasonic Aspirator System510(k)Feb 3, 2022 |
| Connected OR Hub with Device and Voice Control510(k)Dec 16, 2021Gastroenterology, Urology |
| Stryker iBur hubs and cutting accessories510(k)Jun 30, 2021Neurology |
| iBed Wireless with iBed Mobile510(k)Jun 18, 2021General Hospital |
| Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000510(k)Jun 9, 2021Ear, Nose, Throat |