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
1369–1392 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jan 28, 2022
Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311
K213082 · FLL
Guangzhou Berrcom Medical Device Co.,...
General Hospital · 127d
Cleared Jan 28, 2022
iHealth infrared Ear thermometer PT5
K212598 · FLL
Andon Health Co, Ltd.
General Hospital · 165d
Cleared Jan 28, 2022
Surgical Masks
K212120 · FXX
Hubei Xinxin Non-Woven Co., Ltd.
General Hospital · 205d
Cleared Jan 27, 2022
Sterile Auto-Disable Syringes with/without Needle for Single Use
K211210 · FMF
Azur Medical Company, Inc.
General Hospital · 279d
Cleared Jan 26, 2022
Surgical Face Mask
K212610 · FXX
Foshan Nanhai Plus Medical Co, Ltd.
General Hospital · 162d
Cleared Jan 26, 2022
American-Made Surgical Mask
K210101 · FXX
Armbrust, Inc.
General Hospital · 377d
Cleared Jan 25, 2022
ADI Medical Surgical Face Mask
K213347 · FXX
Asia Dynamics Inc., D/B/A Adi Medical
General Hospital · 109d
Cleared Jan 24, 2022
Disposable Syringe with Needle
K211482 · FMF
Shandong Qinkai Medical Industry Co.,...
General Hospital · 257d
Cleared Jan 23, 2022
D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply
K213970 · FXX
Danameco Medical Joint Stock Corporation
General Hospital · 34d
Cleared Jan 23, 2022
Myflon Surgical Mask Level 3
K212111 · FXX
Feliks Plastik Laminasyon VE Ambalaj...
General Hospital · 201d
Cleared Jan 23, 2022
Steiking Packaging for Medical Devices
K210810 · FRG
Wipak OY
General Hospital · 312d
Cleared Jan 23, 2022
Thermoplastic Elastomer (TPE) Hybrid Examination Glove
K210463 · LZA
Xuzhou Full Sun Medical Products , Ltd.
General Hospital · 341d
Cleared Jan 21, 2022
VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM
K213412 · JOJ
Steris Corparation
General Hospital · 94d
Cleared Jan 21, 2022
Nitrile Examination Gloves
K213044 · LZA
Jiangsu Huayuan Medical Technology...
General Hospital · 121d
Cleared Jan 21, 2022
Powder Free Nitrile Patient Examination Gloves, Blue Color
K211864 · LZA
Siyang Jaysun Medtech Co., Ltd.
General Hospital · 219d
Cleared Jan 21, 2022
Infrared Thermometer
K211752 · FLL
Beijing Choice Electronic Technology...
General Hospital · 228d
Cleared Jan 20, 2022
Goody Gloves, Wincare, TBG Gloves
K213075 · LZA
Thai Rubber Gloves Co., Ltd.
General Hospital · 119d
Cleared Jan 20, 2022
Gas-Chex Indicator
K212592 · JOJ
Propper Manufacturing Co., Inc.
General Hospital · 157d
Cleared Jan 20, 2022
Surgical isolation gown
K212357 · FYC
Wuhan Zonsen Medical Products Co., Ltd.
General Hospital · 175d
Cleared Jan 20, 2022
Surgical Face Mask
K203161 · FXX
Wuhan Raytex Protection Co., Ltd.
General Hospital · 454d
Cleared Jan 19, 2022
Powder free Nitrile Examination Glove-(Test for use with Chemotherapy Drugs)
K213227 · LZA
Uweport, LLC
General Hospital · 112d
Cleared Jan 19, 2022
Disposable Medical Mask
K212826 · FXX
Jiangsu Nanfang Medical Co., Ltd.
General Hospital · 138d
Cleared Jan 19, 2022
SHOWA(R) Blue Nitrile Powder Free Medical Examination Glove
K211003 · LZA
Showa Best Glove, Inc.
General Hospital · 292d
Cleared Jan 18, 2022
Microvolume Luer Access Device
K212842 · FPA
B.Braun Medical, Inc.
General Hospital · 133d