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Dispositifs autorisés FDA 510(k) et PMA — 25 produits

Nombre total de dispositifs25
Catégories0
Dernière décision de la FDA
TypeNuméroNom du dispositifCodeDateActions
510(k) K260636 Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingGEI2026-06-18 Voir
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)NLQ2025-08-14 Voir
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)NLF2024-10-22 Voir
510(k) K241606 Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136)NLQ2024-07-03 Voir
510(k) K233471 Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136)NLQ2024-02-20 Voir
510(k) K231621 Reprocessed ViewFlex Xtra ICE Catheter (D087031)OWQ2023-07-25 Voir
510(k) K230251 Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)NUJ2023-03-28 Voir
510(k) K230255 Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019GEI2023-03-28 Voir
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)NLF2022-12-04 Voir
510(k) K220481 Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)GEI2022-05-25 Voir
510(k) K220411 Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)NUJ2022-05-13 Voir
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)NLF2022-03-08 Voir
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 O2DQA2022-03-08 Voir
510(k) K202554 Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced HemostasisNLQ2021-03-16 Voir
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 FluentHIH2020-09-25 Voir
510(k) K201511 Reprocessed Endoscopic Trocars and SleevesNLM2020-07-31 Voir
510(k) K200205 Reprocessed Advisor FL Circular Mapping Catheter, Sensor EnabledNLH2020-05-13 Voir
510(k) K182238 Reprocessed ViewFlex Xtra ICE CatheterOWQ2019-05-08 Voir
510(k) K181056 Reprocessed CS Diagnostic Electrophysiology CatheterNLH2019-01-24 Voir
510(k) K180499 Reprocessed LigaSure Maryland Jaw Sealer/DividerNUJ2018-04-23 Voir
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