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General Hospital devices: recent FDA 510(k) clearances

14 general Hospital devices: recent FDA 510(k) clearances are listed from U.S. FDA openFDA, dated 2026-09-11 to 2026-10-22; the most frequent is B.Braun Medical, Inc. with 1. Data last updated 2026-11-04; 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)

14 records from U.S. FDA openFDA, dated 2026-09-11 to 2026-10-22. Most frequent: B.Braun Medical, Inc. (1). Each record links to a full report and the official source.

Last updated 2026-11-04. Source: U.S. FDA openFDA.

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Records
14
Most frequent
  1. B.Braun Medical, Inc. (1)
  2. Whiteley USA, Inc. (1)
  3. Carecubes, Inc. (1)
  4. Medical Components, Inc. (1)
  5. Ecomed Solutions, LLC (1)

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What are the top general Hospital devices: recent FDA 510(k) clearances right now?

RecordSpecialtyTypeDate
Gravity Blood Sets with 200µm Filter (K260261): 510(k) cleared for B.Braun Medical, Inc.General Hospital510(k)2026-10-22
Endox High Level Disinfectant (K254094): 510(k) cleared for Whiteley USA, Inc.General Hospital510(k)2026-10-16
Carecube Negative Pressure Isolation Chamber (1BY) (K260180): 510(k) cleared for Carecubes, Inc.General Hospital510(k)2026-10-16
Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler (K260080): 510(k) cleared for Medical Components, Inc.General Hospital510(k)2026-10-09
Ecomed Disposable Administration Sets (K254123): 510(k) cleared for Ecomed Solutions, LLCGeneral Hospital510(k)2026-09-11
25G Huber Needle (K254095): 510(k) cleared for Martech Medical ProductsGeneral Hospital510(k)2026-09-18
MOWANA™ Auto Duo (K261266): 510(k) cleared for PENTAMASTER MEDIQ SDN BHDGeneral Hospital510(k)2026-09-17
S.I.N. Instruments Kits (K262084): 510(k) cleared for S.I.N. Implant System LtdaGeneral Hospital510(k)2026-10-22
Endox Test Strips (K263267): 510(k) cleared for Ibt ScientificGeneral Hospital510(k)2026-10-16
Sterilization Cassette (CASS-1) (K262042): 510(k) cleared for Alliedstar Medical Equipment Co., Ltd.General Hospital510(k)2026-10-14
TSK OptiXion (K262516): 510(k) cleared for Tsk Laboratory, JapanGeneral Hospital510(k)2026-10-06
Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid;Non-sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, FeGeneral Hospital510(k)2026-10-01
3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) (K261992): 510(k) cleared for Solventum US, LLCGeneral Hospital510(k)2026-09-25
NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) (K262532): 510(k) cleared for ICU MedicalGeneral Hospital510(k)2026-09-18

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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) Anesthesiology (12) 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) 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 general Hospital devices: recent FDA 510(k) clearances are listed?

14 records from U.S. FDA openFDA, last refreshed automatically. The most recent is dated 2026-10-22.

Can I get alerts for General Hospital devices: recent FDA 510(k) clearances?

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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