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
169–192 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 15, 2025
Zener® (model ZEN-001-B1)
K252128 · FRA
Uvx, Inc.
General Hospital · 70d
Cleared Sep 12, 2025
BD PhaSeal™ Optima Connecting Set (C83-O)
K250059 · ONB
Becton, Dickinson and Company
General Hospital · 245d
Cleared Sep 05, 2025
Vaccess™ CT Low-Profile Power-Injectable Implantable Port
K252478 · LJT
Bard Access Systems, Inc.
General Hospital · 29d
Cleared Sep 05, 2025
High Pressure Tubing
K244038 · DXT
Shandong Int Medical Instruments Co.,...
General Hospital · 249d
Cleared Sep 04, 2025
Fluido® AirGuard System
K251733 · LGZ
The Surgical Company International BV...
General Hospital · 90d
Cleared Aug 29, 2025
EZ™ IV Administration Set
K251814 · FPA
Epic Medical Pte. , Ltd.
General Hospital · 77d
Cleared Aug 28, 2025
Powder-Free Vinyl Exam Gloves, clear
K252505 · LYZ
Basic Medical Technology, Inc.
General Hospital · 20d
Cleared Aug 28, 2025
SmartPilot YpsoMate NS-A2.25
K243901 · QOG
Ypsomed AG
General Hospital · 252d
Cleared Aug 27, 2025
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs,...
K251716 · LZA
Basic Medical Technology, Inc.
General Hospital · 84d
Cleared Aug 22, 2025
Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777)
K243660 · FMF
Cardinalhealth
General Hospital · 268d
Cleared Aug 21, 2025
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use...
K252244 · LZA
Ever Global (Vietnam) Enterprise...
General Hospital · 34d
Cleared Aug 19, 2025
Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested...
K250313 · KGO
Harps Europe Manufacturing GmbH
General Hospital · 197d
Cleared Aug 18, 2025
Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis...
K243604 · LZA
O&M Halyard, Inc.
General Hospital · 270d
Cleared Aug 14, 2025
Cassette Autoclave (ACA5)
K250164 · FLE
Guangzhou Ajax Medical Equipment Co.,...
General Hospital · 205d
Cleared Aug 14, 2025
mOm Essential Incubator (ME1)
K243437 · FMZ
Mom Incubators Limited
General Hospital · 282d
Cleared Aug 05, 2025
Chemfort Female Luer Lock Adaptor
K251411 · ONB
Simplivia Healthcare , Ltd.
General Hospital · 90d
Cleared Aug 05, 2025
trophon2
K250434 · OUJ
Nanosonics
General Hospital · 172d
Cleared Aug 04, 2025
Terragene® Bionova® BT20 Biological Indicator
K251122 · FRC
Terragene
General Hospital · 115d
Cleared Aug 01, 2025
eZSURE™ Empty Fluid Container
K252094 · KPE
Epic Medical Pte. , Ltd.
General Hospital · 29d
Cleared Aug 01, 2025
HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit...
K243458 · LJS
Access Vascular, Inc.
General Hospital · 266d
Cleared Jul 30, 2025
Sterile Nitrile Powder Free Examination Glove Tested for Use with...
K251319 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 92d
Cleared Jul 30, 2025
Intraosseous Infusion Needles
K250724 · FMI
Spectrum Vascular
General Hospital · 142d
Cleared Jul 30, 2025
TSK Syringe
K250127 · QNQ
Tsk Laboratory, Japan
General Hospital · 194d
Cleared Jul 29, 2025
BD Plastipak™ Syringe
K251350 · FMF
Becton, Dickinson and Company
General Hospital · 90d