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
313–336 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Dec 18, 2024
Klockner Kits
K243128 · KCT
SOADCO, S.L.
General Hospital · 79d
Cleared Dec 18, 2024
Lyka® PORT Needle Free Access Device (4170Y)
K241058 · FPA
Quest Medical, Inc.
General Hospital · 244d
Cleared Dec 17, 2024
Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology,...
K242558 · LZA
O&M Halyard, Inc.
General Hospital · 111d
Cleared Dec 17, 2024
Autoclave Indicator Tape
K241036 · JOJ
Jiangmen New Era External Use Drug...
General Hospital · 245d
Cleared Dec 12, 2024
Terragene® Bionova® Photon Process Challenge Device with unique-point...
K242453 · FRC
Terragene S.A.
General Hospital · 115d
Cleared Dec 06, 2024
SmartSiteTM Vented Vial Access Device
K243486 · LHI
Yukon Medical, LLC
General Hospital · 28d
Cleared Dec 04, 2024
Chemical Indicator for enspire CLCSPS (LCC015)
K243475 · JOJ
STERIS Corporation
General Hospital · 26d
Cleared Dec 02, 2024
enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System
K243433 · FEB
STERIS Corporation
General Hospital · 27d
Cleared Dec 02, 2024
GripMate
K243232 · KZH
Synthon Hispania S.L.
General Hospital · 54d
Cleared Nov 27, 2024
Remunity System
K243354 · QJY
Deka Research & Development Corp.
General Hospital · 29d