Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: General Hospital ×
17,825 results
529–552 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 28, 2024
Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use...
K232079 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 259d
Cleared Mar 27, 2024
Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested...
K234097 · LZA
Ever Growth (Vietnam) Corporation...
General Hospital · 92d
Cleared Mar 26, 2024
Removal System Large Bore 60 cc Syringe
K233069 · PUR
Inari Medical, Inc.
General Hospital · 182d
Cleared Mar 22, 2024
BAHADIR STERILIZATION CONTAINERS
K233578 · KCT
Bahadir USA, LLC
General Hospital · 136d
Cleared Mar 22, 2024
Dukal SMS Sterilization Wrap
K233262 · FRG
Dukal, LLC
General Hospital · 175d
Cleared Mar 22, 2024
Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential,...
K231938 · LZA
O&M Halyard, Inc.
General Hospital · 266d
Cleared Mar 20, 2024
Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For...
K232654 · LZA
Nephron Nitrile, LLC
General Hospital · 202d
Cleared Mar 19, 2024
HWJECT Auto-disable syringe
K234024 · FMF
Anhui Hongyu Wuzhou Medical...
General Hospital · 90d
Cleared Mar 19, 2024
Medical Surgical Mask
K231719 · FXX
Azur Medical Company, Inc.
General Hospital · 280d
Cleared Mar 15, 2024
ivWatch® Model 400
K233881 · PMS
Ivwatch, LLC
General Hospital · 98d
Cleared Mar 15, 2024
3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack...
K233814 · FRC
3M Company
General Hospital · 106d
Cleared Mar 15, 2024
Nouvo Safety Set
K232234 · FOZ
Poly Medicure Limited
General Hospital · 232d
Cleared Mar 15, 2024
TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))
K231856 · QNQ
Medexel Co.,Ltd
General Hospital · 266d
Cleared Mar 08, 2024
STERiJECT Low Dead Space, STERiJECT The Invisible Needle
K231734 · QNS
Tsk Laboratory International Japan KK
General Hospital · 268d
Cleared Mar 07, 2024
Safety Sliding Blood Collection Set
K232781 · JKA
Jiangsu Caina Medical Co.,Ltd
General Hospital · 178d
Cleared Mar 06, 2024
Insulin Syringe
K233794 · FMF
Spm Medicare Pvt. , Ltd.
General Hospital · 99d
Cleared Mar 06, 2024
BD SmartSite™ 13mm Vial Access Device
K233021 · LHI
Care Fusion
General Hospital · 166d
Cleared Mar 05, 2024
Medline Open-back Level 3 Protective Gown
K233526 · QPC
Medline Industries, LP
General Hospital · 125d
Cleared Mar 01, 2024
Probe Covers (YF-001, YF-002)
K240023 · FLL
Shenzhen YI Fang Blister Packaging...
General Hospital · 58d
Cleared Mar 01, 2024
Insignis™ Syringe Infusion System
K232328 · FPA
Innovative Health Sciences, LLC
General Hospital · 211d
Cleared Mar 01, 2024
DEKA Infusion System, DEKA Administration Set
K232316 · LDR
Deka Research and Development
General Hospital · 211d
Cleared Mar 01, 2024
Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and...
K231365 · LZA
Anhui Intco Medical Products Co., Ltd.
General Hospital · 295d
Cleared Feb 29, 2024
Powder Free Nitrile Examination Gloves (Blue), Tested For Use With...
K240051 · LZA
Lingshi Hongruida Health Protection...
General Hospital · 52d
Cleared Feb 27, 2024
Praxiject™ SP 0.9% NaCl
K233623 · NGT
Medxl, Inc.
General Hospital · 106d