FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
18529–18552 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 01, 2020
Apolo D / Apolo S
K202388 · KPR
Vmi Tecnologias Ltda
Radiology · 102d
Cleared Dec 01, 2020
Stryker Arthroscope
K202659 · HRX
Stryker
Orthopedic · 78d
Cleared Dec 01, 2020
Confirm Rx Insertable Cardiac Monitor
K202876 · MXC
Abbott (St. Jude Medical)
Cardiovascular · 64d
Cleared Dec 01, 2020
RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP...
K203199 · NVE
STERIS Corporation
General Hospital · 33d
Cleared Nov 30, 2020
Bright High Flow
K200155 · EBF
Genoss Co., Ltd.
Dental · 313d
Cleared Nov 30, 2020
Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical...
K200372 · GEI
Modern Medical Equipment...
General & Plastic Surgery · 290d
Cleared Nov 30, 2020
Avenda Health Treatment System
K201687 · GEX
Avenda Health, Inc.
General & Plastic Surgery · 161d
Cleared Nov 30, 2020
Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy...
K202416 · LZA
Kimberly Clark Corporation
General Hospital · 98d
Cleared Nov 27, 2020
E-Guard
K201173 · MQC
Envisiontec GmbH
Dental · 210d
Cleared Nov 27, 2020
Pulse Oximeter
K201294 · DQA
Guangdong Long Yao Electronic...
Anesthesiology · 197d
Cleared Nov 27, 2020
Axonpen, Axonmonitor, Axonbox, Tablet
K201308 · GWG
Clearmind Biomedical
Neurology · 196d
Cleared Nov 27, 2020
Compex Sport Elite 3.0
K201653 · NGX
Djo, LLC
Physical Medicine · 162d
Cleared Nov 27, 2020
Spo2 Sensor
K202851 · DQA
Jkh USA, LLC
Anesthesiology · 60d
Cleared Nov 27, 2020
Arthrex FiberTak Suture Anchor
K203268 · MBI
Arthrex, Inc.
Orthopedic · 22d
Cleared Nov 25, 2020
SysMed S/T
K192177 · BZD
Sysmed (China) Co., Ltd.
Anesthesiology · 471d
Cleared Nov 25, 2020
CPR Face Shield
K192285 · CBP
Firstar Healthcare Company Limited...
Anesthesiology · 461d
Cleared Nov 25, 2020
AveCure BT Microwave Ablation System
K192406 · NEY
Medwaves, Inc.
Orthopedic · 448d
Cleared Nov 25, 2020
Nipro Dry Complete Dry Acid Concentrate for Hemodialysis
K193155 · KPO
Nipro Renal Solutions USA, Corp.
Gastroenterology & Urology · 377d
Cleared Nov 25, 2020
TopLock Anchor System
K193377 · MBI
Fusion Orthopedics, LLC
Orthopedic · 356d
Cleared Nov 25, 2020
DR-HO'S Electro Therapy Conductive Gel
K200402 · GYB
Guangzhou Xinbo Electronic Co., Ltd.
Neurology · 280d
Cleared Nov 25, 2020
CARTO® 3 EP Navigation System with Signal Processing Unit
K200484 · DQK
Biosense Webster, Inc.
Cardiovascular · 272d
Cleared Nov 25, 2020
Tenax Laser Resistant Endotracheal Tube
K200761 · BTR
Bryan Medical, Inc.
Anesthesiology · 246d
Cleared Nov 25, 2020
SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo,...
K201193 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 205d
Cleared Nov 25, 2020
EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled,...
K202066 · DQK
Abbott Medical
Cardiovascular · 121d