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
4441–4464 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 19, 2025
OPTOVISION Endoscopic Light Source Unit
K243591 · OWN
Optosurgical, LLC
General & Plastic Surgery · 91d
Cleared Feb 19, 2025
Single Use CO2 Laser Fiber (HAF005001)
K243588 · GEX
Quanta System Spa
General & Plastic Surgery · 91d
Cleared Feb 19, 2025
Straumann InLab Validated Workflow
K243478 · NHA
Institut Straumann AG
Dental · 103d
Cleared Feb 19, 2025
Phasix ST Umbilical Hernia Patch
K243241 · OWT
Davol, Inc., A Subsidiary of C.R....
General & Plastic Surgery · 132d
Cleared Feb 19, 2025
Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4,...
K243206 · IRP
Sichuan Qianli-Beoka Medical...
Physical Medicine · 141d
Cleared Feb 19, 2025
Visby Medical Respiratory Health Test
K242526 · QOF
Visby Medical, Inc.
Microbiology · 177d
Cleared Feb 19, 2025
AViTA Pulse Oximeter (SP62B)
K242455 · DQA
Avita Corporation
Anesthesiology · 184d
Cleared Feb 19, 2025
Brainomix 360 e-Lung
K242411 · JAK
Brainomix Limited
Radiology · 189d
Cleared Feb 19, 2025
Microdent Sterilization Cassette
K242023 · KCT
Implant Microdent System S.L.U.
General Hospital · 223d
Cleared Feb 19, 2025
EVOS Pelvic and Acetabular System
K241666 · HRS
Smith & Nephew
Orthopedic · 254d
Cleared Feb 19, 2025
Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323,...
K241578 · DXN
Shenzhen Bsx Technology Electronics...
Cardiovascular · 261d
Cleared Feb 18, 2025
FIX-C 3D Ti ACIF System
K243915 · ODP
Jeil Medical Corporation
Orthopedic · 60d
Cleared Feb 18, 2025
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs,...
K243792 · LZA
Basic Medical Technology, Inc.
General Hospital · 70d
Cleared Feb 18, 2025
AXS Lift Intracranial Base Catheter
K243593 · QJP
Stryker Neurovascular
Neurology · 90d
Cleared Feb 18, 2025
0.04 ZERO ZERO FOUR Male Latex Condom
K243584 · HIS
Okamoto USA, Inc.
Obstetrics & Gynecology · 90d
Cleared Feb 18, 2025
RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port
K243576 · OMP
Smith & Nephew Medical, Ltd.
General & Plastic Surgery · 91d
Cleared Feb 18, 2025
Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and...
K243574 · JWH
Microport Orthopedics, Inc.
Orthopedic · 91d
Cleared Feb 15, 2025
Sway System Sports Plus
K241737 · POM
Sway Medical, Inc.
Neurology · 243d
Cleared Feb 14, 2025
BriefCase-Triage
K250248 · QAS
Aidoc Medical , Ltd.
Radiology · 18d
Cleared Feb 14, 2025
AVIEW CAC
K243696 · QIH
Coreline Soft Co., Ltd.
Radiology · 77d
Cleared Feb 14, 2025
VIA360™ Surgical System
K243503 · MRH
New World Medical, Inc.
Ophthalmic · 94d
Cleared Feb 14, 2025
Brainomix 360 e-ASPECTS
K243294 · POK
Brainomix Limited
Radiology · 119d
Cleared Feb 14, 2025
DESS Dental Smart Solutions
K243212 · NHA
Terrats Medical SL
Dental · 135d
Cleared Feb 14, 2025
Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202,...
K243136 · FLL
Shenzhen Finicare Co., Ltd.
General Hospital · 137d