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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
6409–6432 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 05, 2024
Orthopaedic Surgery Planning Software (AIJOINT)
K233761 · LLZ
Longwood Valley Medical , Ltd.
Radiology · 255d
Cleared Aug 05, 2024
Midfield Light Pipe, 23ga (3269.M06-00)
K233653 · MPA
Peregrine Surgical, LLC
Ophthalmic · 265d
Cleared Aug 05, 2024
Sleepio®
K233577 · QVO
Big Health, Inc.
Neurology · 272d
Cleared Aug 02, 2024
Coronis OneLook
K242008 · PGY
Barco N.V.
Radiology · 23d
Cleared Aug 02, 2024
Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)
K241987 · HIH
Guangzhou Red Pine Medical Instrument...
Obstetrics & Gynecology · 25d
Cleared Aug 02, 2024
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with...
K241970 · LZA
Kanglongda Vietnam Protection...
General Hospital · 28d
Cleared Aug 02, 2024
Innovita HCG Pregnancy Rapid Combo Test
K241919 · JHI
Innovita (Tangshan) Biological...
Chemistry · 32d
Cleared Aug 02, 2024
MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander
K241918 · LCJ
Mentor Worldwide, LLC
General & Plastic Surgery · 32d
Cleared Aug 02, 2024
Cortera™ Spinal Fixation System
K241892 · NKB
Xtant Medical Holdings, Inc.
Orthopedic · 35d
Cleared Aug 02, 2024
Global Modular Replacement System, Modular Replacement System, Modular...
K241716 · JDI
Howmedica Osteonics Corp., Dba...
Orthopedic · 49d
Cleared Aug 02, 2024
Diode Laser Hair Removal System (MBT-Diode Laser)
K241642 · GEX
Beijing Mega Beauty Technology Co., Ltd.
General & Plastic Surgery · 56d
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