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
481–504 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 08, 2024
Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and...
K240021 · LZA
Yue Kang Anhui Medical Products Co.,...
General Hospital · 96d
Cleared Apr 05, 2024
Wireless Smart Thermometer
K233192 · FLL
Famidoc Technology Company Limited
General Hospital · 190d
Cleared Apr 05, 2024
Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene®...
K232103 · QKM
Terragene S.A.
General Hospital · 266d
Cleared Apr 05, 2024
ACTIV™ Cap
K223914 · QBP
Cleansite Medical, Inc.
General Hospital · 463d
Cleared Apr 04, 2024
Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL)
K240361 · LZA
Hebei Titans Hongsen Medical...
General Hospital · 58d
Cleared Apr 04, 2024
Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer
K233026 · FLE
Midmark Corporation
General Hospital · 195d
Cleared Apr 03, 2024
Digital Thermometer
K230889 · FLL
Wenzhou Yosun Medical Technology Co.,Ltd
General Hospital · 369d
Cleared Apr 02, 2024
Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy...
K240080 · LZA
Syntex Healthcare Products Co., Ltd.
General Hospital · 82d
Cleared Apr 02, 2024
R&G Surgical Mask
K232112 · FXX
R&G Seguridad E Higiene Industrial...
General Hospital · 263d
Cleared Apr 01, 2024
Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs...
K233990 · LZA
Shandong Xingyu Gloves Co., Ltd.
General Hospital · 105d
Cleared Mar 29, 2024
Disposable Surgical Gown
K233068 · FYA
Nanning Tecbod Biological Technology...
General Hospital · 185d
Cleared Mar 29, 2024
Dose IQ Safety Software
K230665 · PHC
Baxter Healthcare Corporation
General Hospital · 385d
Cleared Mar 29, 2024
Novum IQ Large Volume Pump
K211122 · FRN
Baxter Healthcare Corporation
General Hospital · 1079d
Cleared Mar 28, 2024
ProSeal™ Injector Plus (Model no. 421050)
K240171 · ONB
Epic Medical Pte. , Ltd.
General Hospital · 66d
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