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
4393–4416 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 24, 2025
Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use...
K243959 · LZC
Lingshi Hongruida Health Protection...
General Hospital · 63d
Cleared Feb 24, 2025
Control-IQ+ technology
K243823 · QJI
Tandem Diabetes Care, Inc.
Chemistry · 74d
Cleared Feb 24, 2025
APRO 70 Swift Catheter and Alembic Aspiration Tubing
K243287 · NRY
Alembic, LLC
Neurology · 129d
Cleared Feb 24, 2025
Ulthera® System
K243035 · OHV
Ulthera, Inc.
General & Plastic Surgery · 150d
Cleared Feb 24, 2025
OncoStudio (OS-01)
K242994 · QKB
Oncosoft. Co., Ltd.
Radiology · 151d
Cleared Feb 24, 2025
SD Implant System
K241703 · DZE
Arum Dentistry Co., Ltd.
Dental · 256d
Cleared Feb 24, 2025
Sterilization Package/Reel
K241565 · FRG
Anqing Clean Dental Instrument...
General Hospital · 269d
Cleared Feb 21, 2025
Xpert® FII & FV
K250218 · NPR
Cepheid
Hematology · 28d
Cleared Feb 21, 2025
Powered Mobility Scooter
K250027 · INI
Intradin (Shanghai) Machinery Co., Ltd.
Physical Medicine · 46d
Cleared Feb 21, 2025
TEMP MASTER, PMMA-based dental resin
K243951 · EBG
Taiwan Dental Materials Co., Ltd.
Dental · 60d
Cleared Feb 21, 2025
VITA YZ Multi Translucent
K243940 · EIH
Vita Zahnfabrik H.Rauter GmbH & Co.
Dental · 63d
Cleared Feb 21, 2025
Primus Spinal Fixation System
K243916 · NKB
Spinal Elements, Inc.
Orthopedic · 63d
Cleared Feb 21, 2025
Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra...
K243640 · HIS
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 88d
Cleared Feb 21, 2025
Materialise Personalized Guides and Models for Craniomaxillofacial Surgery
K243637 · DZJ
Materialise NV
Dental · 88d
Cleared Feb 21, 2025
Sonio Suspect
K243614 · POK
Sonio
Radiology · 91d
Cleared Feb 21, 2025
Medicom Sterilization Pouch and Reel
K243431 · FRG
Medicom Asia-Pacific Holdings Ltd....
General Hospital · 108d
Cleared Feb 21, 2025
LYMA Laser PRO
K243330 · OHS
Lyma Life , Ltd.
General & Plastic Surgery · 120d
Cleared Feb 21, 2025
Custom Abutments
K243278 · NHA
Institut Straumann AG
Dental · 128d
Cleared Feb 21, 2025
Paradigm System
K243258 · OLO
Proprio, Inc.
Orthopedic · 129d
Cleared Feb 21, 2025
Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including...
K243115 · DXN
Shenzhen Urion Technology Co., Ltd.
Cardiovascular · 144d
Cleared Feb 21, 2025
Green X 12 SE (PHT-40CHS)
K243088 · OAS
VATECH Co., Ltd.
Radiology · 144d
Cleared Feb 21, 2025
Sterilization Pouches and Reels
K242898 · FRG
Shanghai Jianzhong Medical Packaging...
General Hospital · 151d
Cleared Feb 21, 2025
Wearable breast pump (model W8)
K242850 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 154d
Cleared Feb 21, 2025
QuickRad
K242838 · LLZ
Aikenist Technologies Pvt, Ltd.
Radiology · 155d