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Stryker Sustainability Solutions

FDA 510(k) & PMA Approved Devices — 24 products

Total Devices24
Categories10
Latest Approval2025-08-14
TypeNumberDevice NameCodeDate
510(k) K250898 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) NLQ 2025-08-14 View
510(k) K241758 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) NLF 2024-10-22 View
510(k) K241606 Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136) NLQ 2024-07-03 View
510(k) K233471 Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136) NLQ 2024-02-20 View
510(k) K231621 Reprocessed ViewFlex Xtra ICE Catheter (D087031) OWQ 2023-07-25 View
510(k) K230251 Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) NUJ 2023-03-28 View
510(k) K230255 Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019 GEI 2023-03-28 View
510(k) K222019 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) NLF 2022-12-04 View
510(k) K220481 Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019) GEI 2022-05-25 View
510(k) K220411 Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) NUJ 2022-05-13 View
510(k) K211140 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 O2 DQA 2022-03-08 View
510(k) K211138 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) NLF 2022-03-08 View
510(k) K202554 Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis NLQ 2021-03-16 View
510(k) K201756 Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reprocessed MyoSure LITE Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device for Fluent HIH 2020-09-25 View
510(k) K201511 Reprocessed Endoscopic Trocars and Sleeves NLM 2020-07-31 View
510(k) K200205 Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled NLH 2020-05-13 View
510(k) K182238 Reprocessed ViewFlex Xtra ICE Catheter OWQ 2019-05-08 View
510(k) K181056 Reprocessed CS Diagnostic Electrophysiology Catheter NLH 2019-01-24 View
510(k) K180499 Reprocessed LigaSure Maryland Jaw Sealer/Divider NUJ 2018-04-23 View
510(k) K180451 Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider NUJ 2018-04-20 View
510(k) K172856 Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider GEI 2017-11-16 View
510(k) K170456 Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology NLQ 2017-04-05 View
510(k) K161693 Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis NLQ 2017-02-23 View
510(k) K153415 Reprocessed Stryker External Fixation Devices KTT 2016-01-13 View