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FDA 510(k) clearances and recalls: Anesthesiology devices

12 FDA 510(k) clearances and recalls: Anesthesiology devices are listed from U.S. FDA openFDA, dated 2026-09-11 to 2026-10-23; the most frequent is Suzhou Yuyue Medical Technology Co., Ltd. with 1. Data last updated 2026-11-03; each record links to its official source and a full report.

Data as of · Compiled by Zalwin from U.S. FDA openFDA

Includes: Record, Specialty, Date, Review days, Recall class, official source URL and score · Card, Apple Pay, Google Pay or Link via Stripe

Free sample: 3 records (CSV)

12 records from U.S. FDA openFDA, dated 2026-09-11 to 2026-10-23. Most frequent: Suzhou Yuyue Medical Technology Co., Ltd. (1). Each record links to a full report and the official source.

Last updated 2026-11-03. Source: U.S. FDA openFDA.

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Records
12
Most frequent
  1. Suzhou Yuyue Medical Technology Co., Ltd. (1)
  2. Endovascular Engineering, Inc. (1)
  3. Aevice Health Pte. , Ltd. (1)
  4. Oxytek Medical Technology Co., Ltd. (1)
  5. Vitaltec Corporation (1)

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What are the top FDA 510(k) clearances and recalls: Anesthesiology devices right now?

RecordSpecialtyTypeDate
BreathCare PAP III (YH-390N) (K260251): 510(k) cleared for Suzhou Yuyue Medical Technology Co., Ltd.Anesthesiology510(k)2026-10-23
Helo™ Return (K253717): 510(k) cleared for Endovascular Engineering, Inc.Anesthesiology510(k)2026-10-11
Aevice Wheeze Detection Module (K260140): 510(k) cleared for Aevice Health Pte. , Ltd.Anesthesiology510(k)2026-09-25
Portable Oxygen Concentrator (OX-1A-E, OX-1B) (K254289): 510(k) cleared for Oxytek Medical Technology Co., Ltd.Anesthesiology510(k)2026-09-23
Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series) (K253063): 510(k) cleared for Vitaltec CorporationAnesthesiology510(k)2026-09-11
Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) (K254171): 510(k) cleared for Shenzhen Mericonn Technology Co., Ltd.Anesthesiology510(k)2026-09-18
Profoject™ LOR Syringe (K261372): 510(k) cleared for CMT Health PTE., Ltd.Anesthesiology510(k)2026-09-25
Altis Full Face Mask (K261262): 510(k) cleared for Respironics, Inc.Anesthesiology510(k)2026-09-25
Disposable Belts for Polysomnography (CNSAC) (K260949): 510(k) cleared for CNSAC Medshop GmbHAnesthesiology510(k)2026-09-24
ElintMAX Respiratory Monitor (ElintMAX Monitor A1) (K260226): 510(k) cleared for Amptron Medical, Inc.Anesthesiology510(k)2026-09-16
Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1) (K263254): 510(k) cleared for Xiamen Compower Medical Tech. Co., Ltd.Anesthesiology510(k)2026-10-16
Glucommander (K261939): 510(k) cleared for Glytec, LLCAnesthesiology510(k)2026-10-05

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510(k) clearances (414) Class II device recalls (320) Class I device recalls (19) Class III device recalls (11)

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Radiology (56) Orthopedic (53) Cardiovascular (52) General & Plastic Surgery (44) Dental (32) Gastroenterology & Urology (27) Neurology (23) Microbiology (21) Clinical Chemistry (15) General Hospital (14) Obstetrics & Gynecology (9) Ophthalmic (7)

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Radiology devices: recent FDA 510(k) clearances (56) Orthopedic devices: recent FDA 510(k) clearances (53) Cardiovascular devices: recent FDA 510(k) clearances (52) General & Plastic Surgery devices: recent FDA 510(k) clearances (44) Dental devices: recent FDA 510(k) clearances (32) Gastroenterology & Urology devices: recent FDA 510(k) clearances (27) Neurology devices: recent FDA 510(k) clearances (23) Microbiology devices: recent FDA 510(k) clearances (21) Clinical Chemistry devices: recent FDA 510(k) clearances (15) General Hospital devices: recent FDA 510(k) clearances (14) Anesthesiology devices: recent FDA 510(k) clearances (12) Obstetrics & Gynecology devices: recent FDA 510(k) clearances (9) Ophthalmic devices: recent FDA 510(k) clearances (7)

Frequently asked questions

How many FDA 510(k) clearances and recalls: Anesthesiology devices are listed?

12 records from U.S. FDA openFDA, last refreshed automatically. The most recent is dated 2026-10-23.

Can I get alerts for Anesthesiology?

Yes. FDAPulse can email you new records matching this filter; plans are listed on the FDAPulse page.

Source: U.S. FDA openFDA. Informational only. RSS feed of new records

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