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
1321–1344 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 02, 2022
Sterile Syringe with Fixed Safety Needle for Single Use
K212652 · MEG
Gemtier Medical (Shanghai), Inc.
General Hospital · 191d
Cleared Mar 02, 2022
Southern Implants Instrument Trays
K210923 · KCT
Southern Implants (Pty), Ltd.
General Hospital · 338d
Cleared Mar 02, 2022
ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number:...
K203376 · FXX
Medtecs (Taiwan) Corp.
General Hospital · 470d
Cleared Mar 01, 2022
Sterile Disposable Temperature Probe
K212945 · FLL
Shenzhen Envisen Industry Co., Ltd.
General Hospital · 167d
Cleared Mar 01, 2022
Sterile Latex Surgical Gloves Powder Free
K212596 · KGO
Amazing Rubber Products Pvt, Ltd.
General Hospital · 197d
Cleared Mar 01, 2022
Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT)
K211776 · FLL
Microlife Intellectual Property GmbH
General Hospital · 265d
Cleared Mar 01, 2022
Disposable Sterile Syringe with Safety Needle
K211484 · MEG
Shinva Ande Healthcare Apparatus Co.,...
General Hospital · 293d
Cleared Mar 01, 2022
Sure-Fine Insulin Syringes
K210848 · FMF
Shina Med Corporation
General Hospital · 344d
Cleared Mar 01, 2022
Vigilant Software Suite – Vigilant Master Med
K210075 · PHC
Fresenius Kabi AG
General Hospital · 413d
Cleared Mar 01, 2022
Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link,...
K210074 · FRN
Fresenius Kabi AG
General Hospital · 413d
Cleared Mar 01, 2022
Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines...
K210073 · FRN
Fresenius Kabi AG
General Hospital · 413d
Cleared Feb 28, 2022
Disposable Nitrile Examination Gloves
K212833 · LZA
Chifeng Huawei Medical...
General Hospital · 174d
Cleared Feb 25, 2022
Ear Thermometer, Model ET005, ET008, ET009
K213084 · FLL
Guangzhou Berrcom Medical Device Co.,...
General Hospital · 155d
Cleared Feb 24, 2022
ROKI Surgical Mask
K214094 · FXX
Roki Co., Ltd.
General Hospital · 58d
Cleared Feb 24, 2022
Sterile Syringe with Safety Needle for Single Use, Sterile Syringe with...
K212949 · MEG
Henan Nursecare Biotechnology Co., Ltd.
General Hospital · 161d
Cleared Feb 24, 2022
Bodygard SFS Surgical Gown Level 3
K202845 · FYA
Feliks Plastik Laminasyon VE Ambalaj...
General Hospital · 517d
Cleared Feb 22, 2022
Enbio S
K213991 · FLE
Enbio Group AG
General Hospital · 63d
Cleared Feb 21, 2022
Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use...
K213548 · LZA
Mercator Medical (Thailand), Ltd.
General Hospital · 105d
Cleared Feb 21, 2022
TMG Nitrile Powder Free Examination Glove
K213500 · LZA
Thai Medical Glove Co., Ltd.
General Hospital · 112d
Cleared Feb 21, 2022
EndoArmor™ + Surgical Gown
K203548 · FYA
Boston Scientific Corporation
General Hospital · 444d
Cleared Feb 20, 2022
Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange
K220232 · LZA
Megine Industries Sdn Bhd
General Hospital · 24d
Cleared Feb 20, 2022
Medical Surgical Mask
K213724 · FXX
Hunan Zhenheyikang Medical Instrument...
General Hospital · 86d
Cleared Feb 19, 2022
Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For...
K214110 · LZA
Mah Sing Healthcare Sdn. Bhd.
General Hospital · 52d
Cleared Feb 19, 2022
Disposable Medical Nitrile Examination Gloves
K213912 · LZA
Jiangsu Maolin Medical Technology...
General Hospital · 66d