Stryker Corporation - FDA 510(k) Cleared Devices
Recent clearances: Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control, 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 System, Sonopet 1Q 3 7cm 1Q Large
81
Total
81
Cleared
0
Denied
FDA 510(k) Regulatory Record - Stryker Corporation General & Plastic Surgery ✕
9 devices
Cleared
Aug 18, 2023
Connected OR Hub with Device and Voice Control, SDC4K Information Management...
General & Plastic Surgery
29d
Cleared
Feb 16, 2023
Sonopet 1Q 3 7cm 1Q Large
General & Plastic Surgery
63d
Cleared
Sep 16, 2022
OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion...
General & Plastic Surgery
157d
Cleared
Feb 03, 2022
Sonopet iQ Ultrasonic Aspirator System
General & Plastic Surgery
57d
Cleared
Dec 16, 2021
Connected OR Hub with Device and Voice Control
General & Plastic Surgery
168d
Cleared
Apr 11, 2019
Sonopet iQ Ultrasonic Aspirator System
General & Plastic Surgery
86d
Cleared
May 03, 2016
SERFAS 90-S Electrosurgical Probe
General & Plastic Surgery
113d
Cleared
Apr 13, 2016
Neptune E-SEP Smoke Evacuation Pencil
General & Plastic Surgery
30d
Cleared
Jan 22, 2016
Stryker Neptune E-SEP Smoke Evacuation Pencil
General & Plastic Surgery
32d