Medical Device Manufacturer · US , Malwah , NJ

Stryker Corporation - FDA 510(k) Cleared Devices

81 submissions · 81 cleared · Since 2010

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

Official Website

81

Total

81

Cleared

0

Denied

FDA 510(k) Regulatory Record - Stryker Corporation Gastroenterology & Urology ✕

4 devices

1-4 of 4

Cleared Feb 26, 2018

Stryker iVAS 13g Bone Biopsy Kit

Gastroenterology & Urology · 20d

Cleared Oct 05, 2017

iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy Kit

Gastroenterology & Urology · 42d

Cleared Mar 19, 2015

Imbibe Aspirating XIA Taps

Gastroenterology & Urology · 94d

Cleared Sep 04, 2014

IVAS 8 GAUGE BONE BIOPSY KIT

Gastroenterology & Urology · 73d