FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
6145–6168 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 02, 2024
Da Vinci Monopolar and Bipolar Adapters (378896)
K241621 · GEI
Intuitive Surgical
General & Plastic Surgery · 58d
Cleared Aug 02, 2024
Actifuse ABX
K241564 · MQV
Baxter Healthcare Corporation
Orthopedic · 63d
Cleared Aug 02, 2024
Medline UNITE® MIS Foot Recon Screw System
K241359 · HWC
Medline Industries, LP
Orthopedic · 80d
Cleared Aug 02, 2024
Thermoforming Sheet Materials (Track A)
K241311 · MQC
Bernhard F?rster GmbH
Dental · 85d
Cleared Aug 02, 2024
Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)
K241268 · BZE
Exceleron Medical
Anesthesiology · 88d
Cleared Aug 02, 2024
Disposable Ureteral Guide Sheath
K241181 · FED
Dongguan Zsr Biomedical Technology...
Gastroenterology & Urology · 95d
Cleared Aug 02, 2024
Air compression leg massager
K240981 · IRP
Huizhou Xinyi Technology Co., Ltd.
Physical Medicine · 114d
Cleared Aug 02, 2024
Samsung ECG App v 1.3 (ECG)
K240909 · QDA
Samsung Electronics Co., Ltd.
Cardiovascular · 122d
Cleared Aug 02, 2024
Acumen Assisted Fluid Management (AFM) Software Feature
K233984 · QMS
Edwards Lifesciences, LLC
Cardiovascular · 228d
Cleared Aug 02, 2024
Moda-flx Hemodialysis System and Cartridge
K233798 · KDI
Diality, Inc.
Gastroenterology & Urology · 247d
Cleared Aug 02, 2024
Bendini Cloud Application
K233706 · OLO
Nuvasive
Orthopedic · 256d
Cleared Aug 02, 2024
Fixone Meniscal Repair
K233601 · MBI
Aju Pharm Co., Ltd.
Orthopedic · 267d
Cleared Aug 02, 2024
GCI Surgical Gown
K233571 · FYA
George Courey, Inc.
General Hospital · 270d
Cleared Aug 02, 2024
Viral Transport Medium
K233534 · JSM
Hardy Diagnostics
Microbiology · 273d
Cleared Aug 02, 2024
MYOTouch Muscle Stimulator
K233098 · IPF
Sunmed, LLC
Physical Medicine · 311d
Cleared Aug 01, 2024
Freefix Forearm Plating System
K242055 · HRS
Skeletal Dynamics, Inc.
Orthopedic · 17d
Cleared Aug 01, 2024
EXULT Knee Replacement System
K242046 · JWH
Corentec Co., Ltd.
Orthopedic · 20d
Cleared Aug 01, 2024
KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2)
K241945 · FGB
Karl Storz SE & CO. KG
Gastroenterology & Urology · 29d
Cleared Aug 01, 2024
Logical Liner
K241690 · MEH
Signature Orthopaedics Pty, Ltd.
Orthopedic · 50d
Cleared Aug 01, 2024
LOOP™ LED Curing Light System (CLK01)
K241238 · EBZ
Garrison Dental Solutions, LLC
Dental · 90d
Cleared Aug 01, 2024
TLAB® Transvenous Liver Biopsy System (TF-18C)
K241145 · DYB
Argon Medical Devices, Inc.
General & Plastic Surgery · 98d
Cleared Aug 01, 2024
ViroZap Indoor Air Purifier, In Duct Model 1008
K241140 · FRA
Applied Photonix, LLC
General Hospital · 99d
Cleared Aug 01, 2024
Clear Moves Aligner
K241137 · NXC
Clear Moves Aligners
Dental · 99d
Cleared Aug 01, 2024
3MP Color LCD Monitor (CL-S301)
K241105 · PGY
Jvckenwood Corporation
Radiology · 101d