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
5161–5184 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 2024
Zimmer® Persona® Personalized Knee System
K243293 · MBH
Zimmer Biomet
Orthopedic · 63d
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
LED Light Therapy Mask...
K243040 · OHS
Shenzhen Siken 3D Technology...
General & Plastic Surgery · 84d
Cleared Dec 20, 2024
Cellbrick Knee Spacer
K243024 · JWH
United Orthopedic Corporation
Orthopedic · 84d
Cleared Dec 20, 2024
KIDS Arterial Filters
K242953 · DTM
Sorin Group Italia S.R.L.
Cardiovascular · 86d
Cleared Dec 20, 2024
Fas Aligner System
K242929 · NXC
Xplora 3D Europe S.L
Dental · 87d
Cleared Dec 20, 2024
SimpleSnip Endoscopic Suture Cutter (SC500160)
K242923 · OCZ
Envision Endoscopy
Gastroenterology & Urology · 87d
Cleared Dec 20, 2024
Finiff System
K242688 · GEI
Skingrab Co., Ltd.
General & Plastic Surgery · 105d
Cleared Dec 20, 2024
SENDERO MAX Delivery Catheter
K242644 · DQY
Okami Medical, Inc.
Cardiovascular · 108d
Cleared Dec 20, 2024
Scooter (PS30)
K242628 · INI
Lichtmega Technology Co., Ltd.
Physical Medicine · 108d
Cleared Dec 20, 2024
aprevo® Digital Planning
K242599 · LLZ
Carlsmed, Inc.
Radiology · 112d
Cleared Dec 20, 2024
TopCEM-Try in Veneer Try-in Gel
K242572 · EBF
Rizhao Huge Biomaterials Company, Ltd.
Dental · 113d
Cleared Dec 20, 2024
HandPICO Fractional Laser Handpiece Tip
K242534 · GEX
Vydence Medical
General & Plastic Surgery · 116d
Cleared Dec 20, 2024
HF-Etchant Hydrofluoric Acid Etching Gel
K242530 · KLE
Rizhao Huge Biomaterials Company, Ltd.
Dental · 116d
Cleared Dec 20, 2024
Tigon Medical All-Suture Anchors (ASA)
K242529 · MBI
Tigon Medical
Orthopedic · 116d
Cleared Dec 20, 2024
Lightning Viewer
K242362 · LLZ
Nexsys Electronics Inc. Dba Medweb
Radiology · 133d
Cleared Dec 20, 2024
Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620)
K242281 · FOZ
Arrow International, LLC (A...
General Hospital · 140d
Cleared Dec 20, 2024
Voluson Expert 18
K242168 · IYN
GE Medical Systems Ultrasound and...
Radiology · 149d
Cleared Dec 20, 2024
Single-use Balloon Dilatation Catheter
K241888 · FGE
Leo Medical Co., Ltd.
Gastroenterology & Urology · 175d
Cleared Dec 20, 2024
Momcozy Wearable Breast Pump (BP311)
K241680 · HGX
Shenzhen Root Innovation Technology...
Obstetrics & Gynecology · 192d
Cleared Dec 20, 2024
Fractional CO2 Laser Therapy System (FG900-S)
K241670 · GEX
Beijing Adss Development Co., Ltd.
General & Plastic Surgery · 192d
Cleared Dec 20, 2024
DASH® SARS-CoV-2 & Flu A/B Test
K241652 · QOF
Nuclein, LLC
Microbiology · 196d
Cleared Dec 20, 2024
Welch Allyn Connex® Spot Monitor
K241411 · MWI
Welch Allyn, Inc.
Cardiovascular · 217d
Cleared Dec 20, 2024
iHealth® Early Pregnancy Test
K241394 · LCX
Andon Health Co, Ltd.
Chemistry · 218d