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
337–360 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 06, 2025
Celerity 5 HP Biological Indicator (LCB052)
K250044 · FRC
STERIS Corporation
General Hospital · 27d
Cleared Feb 06, 2025
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use...
K244034 · LZA
Ever Global (Vietnam) Enterprise...
General Hospital · 38d
Cleared Jan 31, 2025
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs,...
K243441 · LZA
Basic Medical Technology, Inc.
General Hospital · 86d
Cleared Jan 28, 2025
3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE
K243501 · FRC
3M Company
General Hospital · 77d
Cleared Jan 22, 2025
Rio™ Drug Reconstitution Transfer Device
K243985 · LHI
Icu Medical, Inc.
General Hospital · 30d
Cleared Jan 22, 2025
ZeroClear™ Bag Access (423100)
K243976 · ONB
Epic Medical Pte. , Ltd.
General Hospital · 30d
Cleared Jan 17, 2025
HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit...
K243941 · LJS
Access Vascular, Inc.
General Hospital · 28d
Cleared Jan 17, 2025
Babyroo TN300
K243606 · FMT
Draeger Medical Systems, Inc.
General Hospital · 57d
Cleared Jan 17, 2025
Type 5 Integrating Indicator for Steam (CSPN-15)
K242860 · JOJ
True Indicating, LLC
General Hospital · 119d
Cleared Jan 16, 2025
System 9 Sterile Battery Container
K242834 · KCT
Stryker Instruments
General Hospital · 119d
Cleared Jan 16, 2025
Remunity 2.0 Pump for Remodulin (treprostinil) Injection
K241736 · FRN
Deka Research and Development Corp.
General Hospital · 213d
Cleared Jan 15, 2025
Powder Free Nitrile Examination Gloves (Blue, Black), Tested for Use with...
K242936 · LZA
Sunray Medical Products, Inc.
General Hospital · 112d
Cleared Jan 13, 2025
AAMI Level 4 Protective
K242689 · QPC
Azac Group
General Hospital · 129d
Cleared Jan 10, 2025
Safety Winged Blood Collection Sets
K243806 · FMI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 30d
Cleared Jan 08, 2025
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs...
K243818 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 27d
Cleared Jan 08, 2025
ACE Cannula
K242741 · FMI
Ace Medical Industry Co., Ltd.
General Hospital · 119d
Cleared Dec 26, 2024
ProSeal™ Vented Universal Vial Adaptor
K240517 · ONB
Epic Medical Pte. , Ltd.
General Hospital · 307d
Cleared Dec 24, 2024
Insulin Syringes
K242434 · FMF
Chirana T. Injecta
General Hospital · 130d
Cleared Dec 23, 2024
Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min)
K242735 · FRN
Belmont Medical Technologies
General Hospital · 103d
Cleared Dec 23, 2024
Angiography Injector
K242143 · DXT
Shandong Int Medical Instruments Co.,...
General Hospital · 154d
Cleared Dec 23, 2024
Sofjec (Single use Needle)
K241856 · FMF
Hlb Lifescience Co., Ltd.
General Hospital · 179d
Cleared Dec 20, 2024
Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)
K243149 · QLY
Congruence Medical Solutions, LLC
General Hospital · 81d
Cleared Dec 20, 2024
Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620)
K242281 · FOZ
Arrow International, LLC (A...
General Hospital · 140d
Cleared Dec 19, 2024
System 83 Revolve Endoscope Washer/Disinfector
K241168 · FEB
Wassenburg Medical, Inc.
General Hospital · 237d