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
11761–11784 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 01, 2022
Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs
K221747 · LZA
Fitone Latex Products Co., Ltd....
General Hospital · 168d
Cleared Dec 01, 2022
ProBeam 360° Proton Therapy System
K221791 · LHN
Varian Medical Systems, Inc.
Radiology · 163d
Cleared Dec 01, 2022
2-Way 100% Silicone Cleartract Catheter
K222118 · EZL
Silq Technologies, Corp.
Gastroenterology & Urology · 136d
Cleared Dec 01, 2022
Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D,...
K222125 · DXN
Shenzhen AOJ Medical Technology Co.,...
Cardiovascular · 136d
Cleared Dec 01, 2022
CentriMag Pre-connected Pack
K222297 · DTZ
Abbott
Cardiovascular · 122d
Cleared Dec 01, 2022
Chartis Precision Catheter
K222340 · CBI
Pulmonx Corporation
Anesthesiology · 120d
Cleared Dec 01, 2022
MIST IC
K222368 · NHA
Imagine Milling Technologies, LLC
Dental · 118d
Cleared Dec 01, 2022
Mercury® II Spinal System
K222516 · NKB
Spinal Elements, Inc.
Orthopedic · 104d
Cleared Dec 01, 2022
IPL Cooling Hair Removal Device
K222710 · OHT
Shenzhen Siken 3D Technology...
General & Plastic Surgery · 84d
Cleared Dec 01, 2022
Trigon™ HA Stand-Alone Wedge Fixation System
K223226 · PLF
Nvision Biomedical Technologies, Inc.
Orthopedic · 44d
Cleared Nov 30, 2022
Paneffort AAMI Level 3 Isolation Gown
K212717 · FYC
Paneffort, LLC
General Hospital · 460d
Cleared Nov 30, 2022
Neuron-Spectrum-AM with Neuron-Spectrum.NET Software
K220254 · OLT
Neurosoft , Ltd.
Neurology · 303d
Cleared Nov 30, 2022
Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested...
K221082 · LZA
Rhino Health, Inc.
General Hospital · 231d
Cleared Nov 30, 2022
EEA Circular Stapler with Tri-Staple Technology
K221771 · GDW
Covidien
General & Plastic Surgery · 162d
Cleared Nov 30, 2022
Elos Accurate Customized Abutment
K222044 · NHA
Elos Medtech Pinol A/S
Dental · 142d
Cleared Nov 30, 2022
Steripath Micro Blood Collection System
K222299 · JKA
Magnolia Medical Technologies
General Hospital · 121d
Cleared Nov 30, 2022
MissLan™ Digital Pregnancy Rapid Test
K222305 · LCX
Guangzhou Decheng Biotechnology Co.,...
Chemistry · 121d
Cleared Nov 30, 2022
Lancing System, Sterile Lancet for Single Use, Lancing Device
K222472 · QRL
Shandong Lianfa Medical Plastic...
General & Plastic Surgery · 106d
Cleared Nov 30, 2022
Purgo
K223328 · FRA
Aeroclean Technologies, Inc.
General Hospital · 30d
Cleared Nov 29, 2022
QStat Cartridge
K213917 · QFR
Hemosonics, LLC
Hematology · 349d
Cleared Nov 29, 2022
SmartSurgN Visualization System
K213943 · OWN
Smartsurgn Incorporated
General & Plastic Surgery · 347d
Cleared Nov 29, 2022
Disposable Safety Lancet
K222408 · FMK
Beijing Ruicheng Medical Supplies...
General & Plastic Surgery · 111d
Cleared Nov 29, 2022
Signia™ Small Diameter Reloads Including Regular (Round) Tip Version
K222641 · GDW
Covidien
General & Plastic Surgery · 89d
Cleared Nov 28, 2022
Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304
K211050 · FLL
Jkh Health Co., Ltd.
General Hospital · 599d