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Stryker Sustainability Solutions FDA Approvals

0 new drug approvals and 14 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	What it is	Route	Decided
Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating510(k)Jun 18, 2026General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Jun 18, 2026
Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm); Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 36cm); Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears with Advanced Hemostasis x 45cm)510(k)Aug 14, 2025	—	510(k)Substantially Equivalent (Traditional)	Aug 14, 2025
Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed RD SET Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)510(k)Oct 22, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Oct 22, 2024
Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136)510(k)Jul 3, 2024	—	510(k)Substantially Equivalent (Special)	Jul 3, 2024
Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136)510(k)Feb 20, 2024	—	510(k)Substantially Equivalent (Traditional)	Feb 20, 2024
Reprocessed ViewFlex Xtra ICE Catheter (D087031)510(k)Jul 25, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Jul 25, 2023
Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)510(k)Mar 28, 2023General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Special)	Mar 28, 2023
Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019510(k)Mar 28, 2023General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Special)	Mar 28, 2023
Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)510(k)Dec 4, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Dec 4, 2022
Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)510(k)May 25, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	May 25, 2022
Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)510(k)May 13, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	May 13, 2022
Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L), Reprocessed Pulse Oximeter Sensor (D-20), Reprocessed Pulse Oximeter Sensor (N-25), Reprocessed Pulse Oximeter Sensor (I-20), Reprocessed Pulse Oximeter Sensor (Max-A), Reprocessed Pulse Oximeter Sensor (Max-AL), Reprocessed Pulse Oximeter Sensor (Max-P), Reprocessed Pulse Oximeter Sensor (Max-N), Reprocessed Pulse Oximeter Sensor (Max-I)510(k)Mar 8, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Mar 8, 2022
Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2510(k)Mar 8, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Mar 8, 2022
Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis510(k)Mar 16, 2021	—	510(k)Substantially Equivalent (Traditional)	Mar 16, 2021

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