FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,791 results
505–528 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Feb 26, 2024
Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential...
K233560 · LZA
Eco Medi Glove Sdn. Bhd.
General Hospital · 112d
Cleared Feb 16, 2024
SCIg60 Infusion System
K240148 · PKP
Emed Technologies Corporation
General Hospital · 28d
Cleared Feb 16, 2024
Airgle Room Air Purifier
K232645 · FRA
Airgle Corporation
General Hospital · 170d
Cleared Feb 16, 2024
Medline Luer Lock Syringes
K230235 · FMF
Medline Industries, LP
General Hospital · 385d
Cleared Feb 15, 2024
Breathing circuit bacterial/viral filter
K222917 · CAH
Shaoxing Haitech Medical Products...
General Hospital · 507d
Cleared Feb 13, 2024
Black Nitrile Powder Free Patient Examination Glove, Non Sterile
K233740 · LZA
W.A. Rubbermate Co., Ltd.
General Hospital · 83d
Cleared Feb 09, 2024
Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested For Use...
K240072 · LZA
Luliang Hongruida Health Protection...
General Hospital · 30d
Cleared Feb 09, 2024
Infrared Thermometer: Model YJ600
K232473 · FLL
Zhuhai Yueja Medical Device...
General Hospital · 177d
Cleared Feb 08, 2024
Lexa MINI (RIS-303, RIS-305)
K233504 · FLE
W&H Sterilization S.R.L.
General Hospital · 100d
Cleared Feb 07, 2024
Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with...
K232764 · LZA
Eco Medi Glove Sdn. Bhd.
General Hospital · 152d