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
217–240 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Jul 28, 2025
SIGMA Spectrum Infusion Pump with Master Drug Library
K251640 · FRN
Baxter Healthcare Corporation
General Hospital · 60d
Cleared Jul 28, 2025
Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)
K251636 · FRN
Baxter Healthcare Corporation
General Hospital · 60d
Cleared Jul 25, 2025
Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle
K252033 · FMF
CMT Health PTE., Ltd.
General Hospital · 25d
Cleared Jul 25, 2025
BD Nexiva™ Closed IV Catheter System
K243403 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 267d
Cleared Jul 24, 2025
TSK SELECT™ Needle
K250284 · FMI
Tsk Laboratory, Japan
General Hospital · 174d
Cleared Jul 24, 2025
Infusomat® Space Volumetric Infusion Pump Administration Sets
K243392 · FPA
B.Braun Medical, Inc.
General Hospital · 266d
Cleared Jul 22, 2025
Plastic Surgical Kits
K251300 · KCT
Dentsply Sirona, Inc.
General Hospital · 85d
Cleared Jul 22, 2025
Guided DAS Surgical Kit
K243425 · KCT
Talladium Espa?a, SL
General Hospital · 260d
Cleared Jul 18, 2025
HyHub™ and HyHub™ Duo Vial Access Devices
K243404 · LHI
Takeda Pharmaceuticals
General Hospital · 259d
Cleared Jul 11, 2025
BD Cathena™ Safety IV Catheter
K251155 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 88d
Cleared Jul 09, 2025
Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs,...
K250193 · LZA
Basic Medical Technology, Inc.
General Hospital · 167d
Cleared Jul 08, 2025
K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)
K251447 · FMI
Terumo Europe N.V.
General Hospital · 60d
Cleared Jul 08, 2025
Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use...
K250342 · LZA
Encompass Industries Sdn. Bhd.
General Hospital · 152d
Cleared Jul 07, 2025
Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White)
K250496 · LZA
Zibo Shengkun Chemical Industry Co.,...
General Hospital · 137d