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
4705–4728 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 20, 2025
Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91)
K243086 · DQA
Unimed Medical Supplies, Inc.
Anesthesiology · 143d
Cleared Feb 20, 2025
EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)
K242821 · QAS
Ever Fortune.Ai, Co., Ltd.
Radiology · 155d
Cleared Feb 20, 2025
NUSONO Handheld Ultrasound Scanner (NUSONO-C35)
K242681 · IYN
Nurodata, Inc.
Radiology · 167d
Cleared Feb 20, 2025
Falcon HST
K242447 · OLV
Compumedics Limited
Neurology · 188d
Cleared Feb 20, 2025
CaRi-Plaque
K242240 · LLZ
Caristo Diagnostics , Ltd.
Radiology · 205d
Cleared Feb 20, 2025
SperSort™ Sperm Sorting Chip (IPG02)
K241626 · MQK
Ipreg Incorporation
Obstetrics & Gynecology · 259d
Cleared Feb 20, 2025
CORE Shoulder System
K241470 · QHE
LinkBio Corp.
Orthopedic · 272d
Cleared Feb 20, 2025
Medical diode laser systems (CHARISMA, REGAL)
K234004 · GEX
Reveal Lasers , Ltd.
General & Plastic Surgery · 429d
Cleared Feb 19, 2025
Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus
K250473 · EIA
Dci International, LLC
Dental
Cleared Feb 19, 2025
SuperBall-RC™
K244015 · MBI
Arcuro Medical , Ltd.
Orthopedic · 55d
Cleared Feb 19, 2025
A.L.P.S. Small Fragment Plating System
K243761 · HRS
Biomet Orthopedics
Orthopedic · 75d
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