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

Filters: Cleared only ×
175,820 results
29161–29184 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 10, 2017
MOJAVE Expandable Interbody System
K171097 · MAX
K2m, Inc.
Orthopedic · 27d
Cleared May 09, 2017
ExSpiron 1Xi
K162131 · BZK
Respiratory Motion, Inc.
Anesthesiology · 281d
Cleared May 09, 2017
Alpha Pure
K163117 · NJM
Koroad America
Dental · 183d
Cleared May 09, 2017
Oxitone 1000
K163382 · DQA
Oxitone Medical , Ltd.
Anesthesiology · 159d
Cleared May 09, 2017
Digital Blood Pressure Monitor-Automatic Upper Arm Style
K163606 · DXN
Shenzhen Combei Technology Co., Ltd.
Cardiovascular · 139d
Cleared May 09, 2017
Ocata Anterior Cervical System
K170342 · KWQ
Kalitec Direct, LLC
Orthopedic · 95d
Cleared May 09, 2017
Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and...
K170393 · LZA
Zibo Chengxun Automatic Device Co., Ltd.
General Hospital · 90d
Cleared May 09, 2017
NxStage System One Plus
K170469 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 82d
Cleared May 09, 2017
EpiAccess System
K170831 · DYB
Epiep, Inc.
Cardiovascular · 50d
Cleared May 09, 2017
Ablation Confirmation
K171022 · JAK
Neuwave Medical, Inc.
Radiology · 34d
Cleared May 09, 2017
Guider Catheter Introducer
K171081 · DYB
Rhythm Xience, Inc. (Rxi)
Cardiovascular · 28d
Cleared May 09, 2017
Fujifilm Diathermic Slitter (FlushKnife)
K171096 · KGE
Fujifilm Medical Systems U.S.A, Inc.
Gastroenterology & Urology · 26d
Cleared May 08, 2017
Resultz Lice & Egg Removal Kit
K151562 · LJL
Piedmont Pharmaceuticals, LLC
General Hospital · 698d
Cleared May 08, 2017
Fingertip Pulse Oximeter
K161938 · DQA
Xuzhou Yongkang Electronic Science...
Anesthesiology · 298d
Cleared May 08, 2017
Craniomaxillofacial Distraction System (CMFD)
K162594 · MQN
Synthes USA Products, LLC
Dental · 234d
Cleared May 08, 2017
CreoDent Solidex Customized Abutment
K162734 · NHA
Creodent Prosthetics, Ltd.
Dental · 220d
Cleared May 08, 2017
Precifit Medical Kirschner Wires
K163327 · HTY
Precifit Medical, Ltd.
Orthopedic · 161d
Cleared May 08, 2017
Rampart One Lumbar Interbody Fusion Device
K163670 · OVD
Spineology, Inc.
Orthopedic · 132d
Cleared May 08, 2017
Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37
K170111 · OLP
Pulsaderm, LLC
General & Plastic Surgery · 116d
Cleared May 08, 2017
Will3D
K170180 · LLZ
Hdx Will Corp.
Radiology · 109d
Cleared May 08, 2017
Ceribell Pocket EEG Device
K170363 · OMC
Ceribell, Inc.
Neurology · 91d
Cleared May 08, 2017
Venus Silk.expert
K170734 · GEX
Cyden Limited
General & Plastic Surgery · 59d
Cleared May 08, 2017
GORE VIABIL Short Wire Biliary Endoprosthesis
K170740 · FGE
W.L. Gore & Associates, Inc.
Gastroenterology & Urology · 59d
Cleared May 08, 2017
Adhesive Electrodes
K170744 · GXY
Reno Medical , Ltd.
Neurology · 59d