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
241–264 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 03, 2025
3DOSE 1ml Syringe
K250733 · FMF
Bimed Teknik Aletler Sanayi & Ticaret...
General Hospital · 114d
Cleared Jul 03, 2025
BD Vacutainer® Eclipse™ Blood Collection Needle
K243207 · JKA
Becton, Dickinson and Company
General Hospital · 275d
Cleared Jul 01, 2025
Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM)
K251212 · LJS
Access Vascular, Inc.
General Hospital · 74d
Cleared Jun 27, 2025
BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded...
K251654 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 28d
Cleared Jun 26, 2025
Sterilization Pouch and Roll
K243179 · FRG
Yichang Xinxin Paper Products Co., Ltd.
General Hospital · 269d
Cleared Jun 23, 2025
Ear Thermometer (EAR-E101)
K250470 · FLL
Shenzhen AOJ Medical Technology Co.,...
General Hospital · 125d
Cleared Jun 20, 2025
PAL Sterilization Case
K243589 · KCT
Microaire Surgical Instruments, LLC
General Hospital · 212d
Cleared Jun 20, 2025
BD Intelliport System
K243062 · PHC
Becton Dickinson
General Hospital · 266d
Cleared Jun 20, 2025
Reusable Temperature Probe (T1306, T2306, T3306, T4306)
K243000 · FLL
Shenzhen Medke Technology Co., Ltd.
General Hospital · 267d
Cleared Jun 18, 2025
PowerPort™ isp Implantable Port
K251253 · LJT
Bard Access Systems, Inc.
General Hospital · 56d
Cleared Jun 18, 2025
Procedure mask/Surgical mask/Face mask
K250082 · FXX
Winner Medical Co., Ltd.
General Hospital · 156d
Cleared Jun 18, 2025
Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs
K243172 · LZA
O&M Halyard, Inc.
General Hospital · 261d
Cleared Jun 17, 2025
Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested...
K243133 · LZA
Kl-Kepong Rubber Products Sdn. Bhd.
General Hospital · 260d
Cleared Jun 09, 2025
MallyaG Injection Pen Adapter (MallyaG)
K251500 · QOG
Biocorp Production
General Hospital · 25d
Cleared Jun 06, 2025
Celerity 5 HP Biological Indicator (LCB052)
K251452 · FRC
Steris
General Hospital · 28d
Cleared Jun 06, 2025
GCI Sterilization Wrappers
K250321 · FRG
George Courey, Inc.
General Hospital · 122d
Cleared Jun 06, 2025
Steam Sterilizer (2545D)
K243994 · FLE
Ningbo Ican Machines Co., Ltd.
General Hospital · 162d
Cleared Jun 06, 2025
Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract,...
K243694 · LZA
Mah Sing Healthcare Sdn. Bhd.
General Hospital · 189d
Cleared Jun 05, 2025
Clave™ Neutral-Displacement Needlefree Connectors
K250616 · FPA
Icu Medical, Inc.
General Hospital · 97d
Cleared Jun 04, 2025
Blood collection tube holders
K250961 · JKA
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 65d
Cleared Jun 03, 2025
DISINTEK™ PA Test Strips
K251035 · JOJ
Serim Research
General Hospital · 61d
Cleared Jun 03, 2025
BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™...
K250682 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 89d
Cleared Jun 03, 2025
GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for...
K243796 · LZA
Glove One, LLC
General Hospital · 175d
Cleared May 30, 2025
ViVi® Toga Premium
K243522 · FYA
Thi Total Healthcare Innovation GmbH
General Hospital · 197d