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
385–408 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 25, 2024
LDS Needle
K242956 · QNS
Ocuject, LLC
General Hospital · 30d
Cleared Oct 25, 2024
Nitrile Powder Free Examination Gloves Biodegradable (Green)
K240269 · LZA
Comfort Rubber Gloves Industries Sdn....
General Hospital · 268d
Cleared Oct 25, 2024
FMT Disposable and Autoclavable Temperature Probes
K240223 · FLL
Metko Medikal VE Tibbi Cihazlar Dis...
General Hospital · 273d
Cleared Oct 23, 2024
STERiJECT Ophthalmic Needle
K242073 · QYM
Tsk Laboratory International Japan KK
General Hospital · 99d
Cleared Oct 23, 2024
ProSeal™ Closed System Bag Access
K241988 · ONB
Epic Medical Pte. , Ltd.
General Hospital · 107d
Cleared Oct 22, 2024
Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without...
K242099 · FMF
Sol-Millennium Medical, Inc.
General Hospital · 96d
Cleared Oct 18, 2024
3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD)
K241959 · FRC
3M Company
General Hospital · 107d
Cleared Oct 18, 2024
Surgical Face Mask (Tie on/ Ear loops)
K240916 · FXX
Xiantao Daoqi Plastic Co., Ltd.
General Hospital · 198d
Cleared Oct 16, 2024
Safe Secure Sterilization Pouches and Rolls
K242839 · FRG
Shenzhen Safesecure Medical Infection...
General Hospital · 27d
Cleared Oct 16, 2024
Stryker Steri-Shield 8 Surgical Hoods and Togas
K241272 · FYA
Stryker Instruments
General Hospital · 163d
Cleared Oct 15, 2024
Getinge Assured MI Steam Migrating Integrator
K242795 · JOJ
Steritec Products Mfg. (A Getinge...
General Hospital · 29d
Cleared Oct 12, 2024
NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs)
K242812 · LZA
Nb Medical Company Limited
General Hospital · 24d
Cleared Oct 10, 2024
ProSeal™ In Line Pump Set (423850)
K241735 · ONB
Epic Medical Pte. , Ltd.
General Hospital · 115d
Cleared Oct 07, 2024
DEKA Infusion System, DEKA Administration Set
K242693 · LDR
Deka Research and Development...
General Hospital · 28d
Cleared Oct 07, 2024
PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
K242208 · FRG
Primed Medical Products, Inc.
General Hospital · 70d
Cleared Oct 07, 2024
SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)
K242152 · MEB
Epic Medical Pte. , Ltd.
General Hospital · 76d
Cleared Oct 03, 2024
Curlin 8000 Ambulatory Infusion System
K242660 · FRN
Zevex, Inc.
General Hospital · 29d
Cleared Sep 30, 2024
Kem Medical Lead-free Chemical Indicators for Steam Sterilization
K241836 · JOJ
Kem Medical Products Corporation
General Hospital · 97d
Cleared Sep 27, 2024
Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential,...
K241909 · LZA
O&M Halyard, Inc.
General Hospital · 88d
Cleared Sep 27, 2024
trophon Wireless Ultrasound Probe Holder
K241536 · OUJ
Nanosonics Limited
General Hospital · 120d
Cleared Sep 27, 2024
Aulisa Temperature Module (TM0002)
K240220 · FLL
Taiwan Aulisa Medical Devices...
General Hospital · 245d
Cleared Sep 26, 2024
Verifine® Pen Needles
K242632 · FMI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 23d
Cleared Sep 20, 2024
Luer Lock Syringe with Safety Needle
K241821 · FMF
Sol-Millennium Medical, Inc.
General Hospital · 88d
Cleared Sep 20, 2024
Ecomed Disposable Administration Sets
K234129 · FPA
Ecomed Solutions, LLC
General Hospital · 267d