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
16465–16488 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 18, 2021
sam X1 Long Duration Ultrasound Device
K211513 · PFW
ZetrOZ Systems, LLC
Physical Medicine · 96d
Cleared Aug 18, 2021
Surgical Face Mask
K211631 · FXX
Macheng Thimble Technology Investment...
General Hospital · 83d
Cleared Aug 18, 2021
Triton
K211813 · KJJ
Inter-Med / Vista Dental
Dental · 68d
Cleared Aug 18, 2021
QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments
K211957 · NKG
Globus Medical, Inc.
Orthopedic · 55d
Cleared Aug 18, 2021
Disposable medical surgical mask
K212097 · FXX
Hebei Titans Hongsen Medical...
General Hospital · 43d
Cleared Aug 18, 2021
Cellvizio I.V.E. system with Confocal Miniprobes
K212322 · OWN
Mauna Kea Technologies
General & Plastic Surgery · 23d
Cleared Aug 17, 2021
Brain Perfusion (BP) application
K201573 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 432d
Cleared Aug 17, 2021
Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
K203089 · QDK
Dexcom, Inc.
Chemistry · 308d
Cleared Aug 17, 2021
ASPIVIX v1.1 Cervical Suction Tenaculum
K203820 · HDC
Aspivix SA
Obstetrics & Gynecology · 231d
Cleared Aug 17, 2021
Deep Transcranial Magnetic Stimulation (DTMS) System
K210201 · OBP
Brainsway , Ltd.
Neurology · 204d
Cleared Aug 17, 2021
ROSA Hip System
K210998 · LLZ
Orthosoft D/B/A Zimmer Cas
Radiology · 137d
Cleared Aug 17, 2021
STARband
K211376 · OAN
Orthomerica Products, Inc.
Neurology · 105d
Cleared Aug 17, 2021
Journey II Mid-Level Tibial Inserts
K211671 · JWH
Smith & Nephew, Inc.
Orthopedic · 77d
Cleared Aug 17, 2021
Disposable Medical Nitrile Gloves
K211708 · LZA
Jiangsu Health-Peace Medical...
General Hospital · 75d
Cleared Aug 16, 2021
iMap 3D Mapping & Navigation System (iMap System)
K201094 · DQK
Cardionxt, Inc.
Cardiovascular · 479d
Cleared Aug 16, 2021
Metallic Fabric Electrodes
K202636 · GXY
Guangzhou Xinbo Electronic Co., Ltd.
Neurology · 339d
Cleared Aug 16, 2021
Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove
K203236 · LZA
Rhino Health, Inc.
General Hospital · 286d
Cleared Aug 16, 2021
Disposable Monopolar Laparoscopic Shafts and Reusable Handles
K210569 · GEI
Dannik, LLC
General & Plastic Surgery · 171d
Cleared Aug 16, 2021
CPM Medical Consultants Tibial Revision Knee System
K210695 · JWH
Cpm Medical Consultants, LLC
Orthopedic · 161d
Cleared Aug 16, 2021
NuVent Eustachian Tube Dilation Balloon
K210841 · PNZ
Medtronic Xomed, Inc.
Ear, Nose, Throat · 147d
Cleared Aug 16, 2021
Multi-Link X2 ECG Cable and Leadwire System
K211294 · DSA
Vyaire Medical, Inc.
Cardiovascular · 110d
Cleared Aug 16, 2021
Penumbra System (Reperfusion Catheter RED 72)
K211654 · NRY
Penumbra, Inc.
Neurology · 80d
Cleared Aug 16, 2021
Insignia Hip Stem
K211703 · MEH
Stryker Orthopaedics
Orthopedic · 74d
Cleared Aug 16, 2021
Adena-Zina System
K212066 · NKB
Shanghai Sanyou Medical Co, Ltd.
Orthopedic · 45d