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
73–96 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 08, 2026
SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700
K251666 · MED
STERIS Corporation
General Hospital · 313d
Cleared Apr 07, 2026
Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)
K260860 · LYZ
Basic Medical Technology, Inc.
General Hospital · 22d
Cleared Apr 02, 2026
BD Insyte™ IV Catheter
K252137 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 268d
Cleared Apr 02, 2026
LifeShield Infusion Safety Software Suite
K252130 · PHC
Icu Medical, Inc.
General Hospital · 269d
Cleared Apr 02, 2026
Disposable Infusion Bag for Parenteral Nutrition
K252079 · KPE
Beijing L&Z Medical Technology...
General Hospital · 274d
Cleared Apr 01, 2026
Polywin Safety (14G x 51mm
K252513 · FOZ
Poly Medicure Limited
General Hospital · 233d
Cleared Mar 27, 2026
OTTO™ Disinfecting Cap
K252006 · QBP
Icu Medical, Inc.
General Hospital · 273d
Cleared Mar 25, 2026
Easydrip Classic Pen Needle
K252908 · FMI
Sandstone Medical (Suzhou), Inc.
General Hospital · 194d
Cleared Mar 24, 2026
PRESSONE™
K253047 · FMI
Nipro Medical Corporation
General Hospital · 183d
Cleared Mar 20, 2026
ClaveQS™ Bag
K251980 · KPE
Icu Medical, Inc.
General Hospital · 266d
Cleared Mar 18, 2026
Safety Pen Needle
K253622 · FMI
Ningbo Medsun Medical Co., Ltd.
General Hospital · 120d
Cleared Mar 18, 2026
HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO...
K251967 · FXX
O&M Halyard, Inc.
General Hospital · 265d
Cleared Mar 05, 2026
CORIS System
K253267 · SEW
Nanosonics Limited
General Hospital · 157d
Cleared Mar 05, 2026
Extension tube
K251788 · DXT
Zhuhai DR Medical Instruments Co., Ltd.
General Hospital · 267d
Cleared Mar 03, 2026
Surgical Face Mask (Ear mount)
K252534 · FXX
Zhejiang Hangkang Medical Equipment...
General Hospital · 203d
Cleared Feb 26, 2026
Enbio PRO
K260254 · FLE
Enbio Group AG
General Hospital · 30d
Cleared Feb 26, 2026
PUREVUE™ Quick Connect Cannula System Tray
K253791 · KCT
DePuy Mitek, Inc.
General Hospital · 90d
Cleared Feb 26, 2026
Copioumed AAMI 3 Surgical Gown
K251860 · FYA
Copioumed International, Inc.
General Hospital · 254d
Cleared Feb 23, 2026
Profoject™ Insulin Syringes
K253068 · FMF
CMT Health PTE., Ltd.
General Hospital · 154d
Cleared Feb 20, 2026
LF Process Indicator Tape for Steam Sterilization
K260181 · JOJ
Intertape Polymer Group
General Hospital · 30d
Cleared Feb 19, 2026
Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)
K253398 · FXX
Efofex, Inc.
General Hospital · 142d
Cleared Feb 19, 2026
Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe
K252814 · QNQ
CMT Health PTE., Ltd.
General Hospital · 168d
Cleared Feb 18, 2026
PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)
K252098 · MEG
Methyl Co., Ltd.
General Hospital · 230d
Cleared Feb 13, 2026
MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit
K252891 · DXT
Bayer Medical Care, Inc.
General Hospital · 155d