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
29977–30000 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 06, 2017
Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor...
K162014 · DQA
Bluepoint Medical GmbH & Co. KG
Anesthesiology · 200d
Cleared Feb 06, 2017
DCM Kyphoplasty System
K162283 · NDN
Dragon Crown Medical Co., Ltd.
Orthopedic · 175d
Cleared Feb 06, 2017
NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS...
K162923 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 111d
Cleared Feb 06, 2017
EndoWrist Suction Irrigator
K162973 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 104d
Cleared Feb 06, 2017
Altus Spine Cervical Plate System
K163061 · KWQ
Altus Partners, LLC
Orthopedic · 97d
Cleared Feb 06, 2017
syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology
K163294 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 76d
Cleared Feb 06, 2017
3M Protemp Cement Temporary Dental Cement
K170330 · EMA
3M Company
Dental · 4d
Cleared Feb 03, 2017
ActiPatch(R)
K152432 · PQY
Bioelectronics Corporation
Physical Medicine · 526d
Cleared Feb 03, 2017
priti multidisc ZrO2 High Translucent
K161025 · EIH
Pritidenta GmbH
Dental · 297d
Cleared Feb 03, 2017
Telemetry Transmitter
K161056 · MHX
Edan Instruments, Inc.
Cardiovascular · 295d
Cleared Feb 03, 2017
NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit
K161258 · MOB
Inova Diagnostics, Inc.
Immunology · 275d
Cleared Feb 03, 2017
TrapLiner catheter
K161901 · DQY
Vascular Solutions, Inc.
Cardiovascular · 207d
Cleared Feb 03, 2017
Micro-current Wrinkle Reduction Facial service, model EP-400
K162106 · NFO
Li-Tek Electronic Technology Corporation
Neurology · 189d
Cleared Feb 03, 2017
CuraSeal Percutaneous Intraluminal Closure System for Anorectal...
K162388 · FTM
Curaseal, Inc.
General & Plastic Surgery · 162d
Cleared Feb 03, 2017
AxSOS 3 Ti
K162439 · HRS
Stryker GmbH
Orthopedic · 156d
Cleared Feb 03, 2017
GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated...
K162536 · MVL
Kerr Corporation
Dental · 144d
Cleared Feb 03, 2017
RehaStim 2
K162683 · GZI
Hasomed GmbH
Neurology · 130d
Cleared Feb 03, 2017
MTM Clear Aligner
K163155 · NXC
Dentsply Sirona
Dental · 85d
Cleared Feb 03, 2017
PICC Maximal Barrier Nursing Kit
K163452 · LJS
Navilyst Medical, Inc.
General Hospital · 56d
Cleared Feb 03, 2017
LenSx Laser System
K163551 · OOE
Alcon Laboratories, Inc.
Ophthalmic · 46d
Cleared Feb 02, 2017
Titan 3W
K160835 · INI
Tzora Active Systems , Ltd.
Physical Medicine · 314d
Cleared Feb 02, 2017
US SA Implant System
K161103 · DZE
Osstem Implant Co., Ltd.
Dental · 289d
Cleared Feb 02, 2017
0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe
K161552 · NGT
Becton, Dickinson and Company
General Hospital · 241d
Cleared Feb 02, 2017
Q-Switched Nd:YAG Laser Therapy Systems
K163123 · GEX
Beijing Sincoheren Science and...
General & Plastic Surgery · 86d