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
5545–5568 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 14, 2024
Intense Pulsed Light Treatment System (LK-PT)
K242440 · ONF
Nanjing Bestview Laser S&T Co., Ltd.
General & Plastic Surgery · 90d
Cleared Nov 14, 2024
Proximal Humerus Fixation System
K242436 · HRS
Skeletal Dynamics, Inc.
Orthopedic · 90d
Cleared Nov 14, 2024
Fetal EchoScan
K242342 · POK
Brightheart
Radiology · 99d
Cleared Nov 14, 2024
Arthrex Elbow Fracture Plating System
K242079 · HRS
Arthrex, Inc.
Orthopedic · 121d
Cleared Nov 14, 2024
Veincare
K241930 · GEX
Wontech Co., Ltd.
General & Plastic Surgery · 136d
Cleared Nov 14, 2024
Hinscope
K241397 · MSX
Hinlab Sas
Cardiovascular · 182d
Cleared Nov 14, 2024
Besmed Bacterial Filter and HMEF
K241339 · CAH
Besmed Health Business Corp
General Hospital · 185d
Cleared Nov 13, 2024
CeQur Simplicity™ On-Demand Insulin Delivery System
K243273 · OPP
Cequr SA
Chemistry · 28d
Cleared Nov 13, 2024
LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone...
K242856 · FRO
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 54d
Cleared Nov 13, 2024
MediRod Pedicle Screw System
K242764 · NKB
Cmf Medicon Surgical, Inc.
Orthopedic · 61d
Cleared Nov 13, 2024
Dental Glass Ceramics Blocks (HT, LT, MT)
K242407 · EIH
Hunan Vsmile Biotechnology Co., Ltd.
Dental · 91d
Cleared Nov 13, 2024
RESPOND(R) Ventilator
K241135 · CBK
Corvent Medical, Inc.
Anesthesiology · 203d
Cleared Nov 13, 2024
Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW,...
K240337 · EFB
Guangdong Jinme Medical Technology...
Dental · 282d
Cleared Nov 13, 2024
Nonin OTC Pulse Oximeter Model 3250
K211498 · OLK
Nonin Medical, Inc.
Anesthesiology · 1279d
Cleared Nov 12, 2024
Electric wheelchair (KR-8807)
K242791 · ITI
Zhejiang Kairui Medical Device Co., Ltd.
Physical Medicine · 57d
Cleared Nov 12, 2024
InPen System App (MMT-8060 (iOS), MMT-8061 (Android))
K242775 · NDC
Medtronic Minimed
Chemistry · 60d
Cleared Nov 12, 2024
Aurelia Surgical Mask ASTM Level-3 (2130)
K242502 · FXX
Supermax Healthcare Canada-Supermax...
General Hospital · 82d
Cleared Nov 12, 2024
Power-Flex (PFX1214)
K242430 · ITI
Soul Mobility
Physical Medicine · 89d
Cleared Nov 12, 2024
pNOVUS 21 Microcatheter
K242420 · DQO
Phenox, Ltd.
Neurology · 89d
Cleared Nov 12, 2024
Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10,...
K242173 · FED
Coloplast Corp.
Gastroenterology & Urology · 111d
Cleared Nov 12, 2024
UbiqVue™ 2A Multi-parameter System (UX2550)
K242018 · DRG
Lifesignals, Inc.
Cardiovascular · 125d
Cleared Nov 12, 2024
Change Healthcare Stratus Imaging PACS
K241981 · LLZ
Change Healthcare Canada Company
Radiology · 130d
Cleared Nov 12, 2024
High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22),...
K241074 · EFB
Foshan Soco Precision Instrument Co.,...
Dental · 207d
Cleared Nov 12, 2024
PRORAD X-Ray Flat Panel Detector with DROC
K240771 · MQB
Prognosys Medical Systems Private...
Radiology · 236d