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
193–216 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
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