Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: General Hospital ×
17,825 results
97–120 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 24, 2026
SMARTeZ™ Elastomeric Infusion Pump (RS series)
K250234 · MEB
Epic Medical Pte. , Ltd.
General Hospital · 452d
Cleared Apr 22, 2026
Verrix EVA™ STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA™ STEAM...
K252306 · QVB
Steritec Products
General Hospital · 272d
Cleared Apr 20, 2026
Luminoah FLOW™ Enteral Nutrition System
K253558 · LZH
Luminoah
General Hospital · 154d
Cleared Apr 20, 2026
Non-sterile Level 3 Surgical Gown (4025)
K253003 · FYA
Hubei Xinxin Non-Woven Co., Ltd.
General Hospital · 213d
Cleared Apr 17, 2026
Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)
K252279 · FMF
Chirana T.Injecta,A.S.
General Hospital · 269d
Cleared Apr 16, 2026
Verisafe Safety Sterile Needles (SSN)
K254273 · FMI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 107d
Cleared Apr 16, 2026
High Pressure Syringe
K253048 · DXT
Shenzhen Maiwei Biotech Co., Ltd.
General Hospital · 206d
Cleared Apr 15, 2026
STERRAD 100NX Sterilization System with ALLClear Technology (10104)
K252843 · MLR
Advanced Sterilization Products, Inc.
General Hospital · 219d
Cleared Apr 10, 2026
BD Vacutainer® Safety-Lok™ Blood Collection Set
K252506 · JKA
Becton, Dickinson and Company
General Hospital · 245d
Cleared Apr 08, 2026
Celerity 5 HP Biological Indicator (LCB052)
K260766 · FRC
STERIS Corporation
General Hospital · 30d
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