Medical Device Manufacturer · US , Tempe , AZ

Stryker Sustainability Solutions - FDA 510(k) Cleared Devices

31 submissions · 31 cleared · Since 2011

Recent clearances: Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm), Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120)

31

Total

31

Cleared

0

Denied

FDA 510(k) Regulatory Record - Stryker Sustainability Solutions Cardiovascular ✕

6 devices

1-6 of 6

Cleared Jul 25, 2023

Reprocessed ViewFlex Xtra ICE Catheter (D087031)

Cardiovascular · 53d

Cleared May 13, 2020

Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled

Cardiovascular · 106d

Cleared May 08, 2019

Reprocessed ViewFlex Xtra ICE Catheter

Cardiovascular · 261d

Cleared Jan 24, 2019

Reprocessed CS Diagnostic Electrophysiology Catheter

Cardiovascular · 279d

Cleared Oct 21, 2011

REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER

Cardiovascular · 72d

Cleared Sep 26, 2011

REPROCESSED ELECTROPHYSIOLOGY CATHETERS

Cardiovascular · 53d