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
21409–21432 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 02, 2019
Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)
K190009 · NUH
Hong Qiangxing (Shenzhen) Electronics...
Neurology · 333d
Cleared Dec 02, 2019
Integra TITAN Reverse Shoulder System
K190588 · PHX
Integra LifeSciences Corporation
Orthopedic · 270d
Cleared Dec 02, 2019
Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via...
K190659 · FAD
Allwin Medical Devices, Inc.
Gastroenterology & Urology · 263d
Cleared Dec 02, 2019
mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs...
K190876 · LZA
Mercator Medical (Thailand), Ltd.
General Hospital · 242d
Cleared Dec 02, 2019
Uroject12 Syringe Lever
K190987 · QBL
Urogen Pharma, Ltd.
Gastroenterology & Urology · 231d
Cleared Dec 02, 2019
Checkme O2 Pulse Oximeter
K191088 · DQA
Shenzhen Viatom Technology Co., Ltd.
Anesthesiology · 222d
Cleared Dec 02, 2019
Zipbond
K191656 · KLE
Sdi Limited
Dental · 164d
Cleared Dec 02, 2019
Vital Navigation System
K191722 · OLO
Zimmer Biomet Spine, Inc.
Orthopedic · 158d
Cleared Dec 02, 2019
Emprint Visualization Application
K192038 · LLZ
Covidien, LLC
Radiology · 125d
Cleared Dec 02, 2019
Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip
K192374 · FXX
Cardinal Health200, LLC
General Hospital · 94d
Cleared Dec 02, 2019
Hi-Fatigue Bone Cement
K192394 · LOD
Osartis GmbH
Orthopedic · 90d
Cleared Dec 02, 2019
Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet
K192666 · FMK
Promisemed Hangzhou Meditech Co., Ltd.
General & Plastic Surgery · 68d
Cleared Nov 30, 2019
Resorbable Mesh Device
K193040 · MQV
SeaSpine Orthopedics Corporation
Orthopedic · 30d
Cleared Nov 29, 2019
EliA SymphonyS Immunoassay
K190710 · LLL
Phadia AB
Immunology · 255d
Cleared Nov 29, 2019
Innonix Antiviral Child's Face Mask
K192105 · OUK
Innonix Technologies Limited
General Hospital · 116d
Cleared CT Nov 29, 2019
I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System,...
K192186 · GWN
Neurolign USA, LLC
Ear, Nose, Throat · 109d
Cleared Nov 29, 2019
Shoulder Innovations Total Shoulder System
K192365 · KWT
Shoulder Innovations, Inc.
Orthopedic · 91d
Cleared Nov 29, 2019
ASAHI CROSSWALK Peripheral Support Catheter
K192782 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 60d
Cleared Nov 29, 2019
AXS Infinity LS Plus Long Sheath
K193034 · DQY
Stryker Neurovascular
Neurology · 29d
Cleared Nov 27, 2019
World Knee Total Knee Systems
K190577 · JWH
Signature Orthopaedics Pty, Ltd.
Orthopedic · 266d
Cleared Nov 27, 2019
Optimus NEURO System - Sterile Kit
K190811 · GWO
Osteonic Co., Ltd.
Neurology · 243d
Cleared Nov 27, 2019
Hypotension Decision Assist
K190955 · DXG
Directed Systems, Ltd.
Cardiovascular · 230d
Cleared Nov 27, 2019
fMRI Hardware System
K191032 · LNH
Nordicneurolab AS
Radiology · 223d
Cleared Nov 27, 2019
ECG Cable
K191428 · DSA
Shenzhen Changke Connect Electronics...
Cardiovascular · 182d