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
15313–15336 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 2021
Non Absorbable Surgical Nylon Suture
K212603 · GAR
Shandong Haidike Medical Product Co.,...
General & Plastic Surgery · 127d
Cleared Dec 22, 2021
SleepRight Select-Comfort Dental Guard
K212767 · MQC
Splintek, Inc.
Dental · 113d
Cleared Dec 22, 2021
Glovmaster Nitrile Examination Glove Powder Free
K212914 · LZA
Glovmaster Sdn. Bhd.
General Hospital · 100d
Cleared Dec 22, 2021
Oren LED Perioral Light Therapy System
K213024 · OHS
Shenzhen Kaiyan Medical CO , Ltd.
General & Plastic Surgery · 92d
Cleared Dec 22, 2021
ID-500 iRestore Hair Growth System
K213094 · OAP
Freedom Laser Therapy, Inc.
General & Plastic Surgery · 89d
Cleared Dec 22, 2021
Claritas iPET
K213140 · LLZ
Claritas Healthtech Pte, Ltd.
Radiology · 86d
Cleared Dec 22, 2021
Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors
K213144 · LYZ
Shen Wei (Usa), Inc.
General Hospital · 86d
Cleared Dec 22, 2021
Encore System
K213159 · ORY
Siesta Medical, Inc.
Dental · 85d
Cleared Dec 22, 2021
Sheath, Stopcock Accessory
K213207 · HIH
Olympus Winter & Ibe GmbH
Obstetrics & Gynecology · 84d
Cleared Dec 22, 2021
Diode Laser System GP900A8, Diode Laser System GP900Q8
K213225 · GEX
Shenzhen Gsd Tech Co., Ltd.
General & Plastic Surgery · 84d
Cleared Dec 22, 2021
iSR’obot Mona Lisa 2.0
K213411 · IYO
Biobot Surgical Pte., Ltd.
Radiology · 64d
Cleared Dec 22, 2021
EdgePro
K213428 · NVK
Biolase, Inc.
Dental · 62d
Cleared Dec 22, 2021
Solas OR
K213691 · MWP
Cirdan Imaging, Ltd.
Radiology · 29d
Cleared Dec 21, 2021
Wesper Lab
K203343 · MNR
Wesper, Inc.
Anesthesiology · 403d
Cleared Dec 21, 2021
TRI-matrix Implant Line
K203660 · DZE
Tri Dental Implants Int. AG
Dental · 371d
Cleared Dec 21, 2021
Meticuly Patient-Specific Titanium Mesh Implant
K210099 · GXN
Meticuly Co., Ltd.
Neurology · 341d
Cleared Dec 21, 2021
CardiaMend Pericardial and Epicardial Reconstruction Matrix
K210331 · PSQ
Helios Cardio, Inc.
Cardiovascular · 319d
Cleared Dec 21, 2021
BU-CAD
K210670 · QDQ
Taihao Medical, Inc.
Radiology · 291d
Cleared Dec 21, 2021
reVive Light Therapy Essentials
K210968 · OLP
Led Technologies, Inc.
General & Plastic Surgery · 265d
Cleared Dec 21, 2021
Progreat Lambda
K211078 · DQO
Terumo Clinical Supply Co., Ltd.
Cardiovascular · 253d
Cleared Dec 21, 2021
The Progen™ Trochanteric Nail System
K211086 · HSB
Ortho Development Corporation
Orthopedic · 253d
Cleared Dec 21, 2021
N1 TiUltra TCC Implant System
K211109 · DZE
Nobel Biocare Services AG
Dental · 251d
Cleared Dec 21, 2021
iCOquit® Smokerlyzer®
K211918 · CCJ
Bedfont Scientific, Ltd.
Toxicology · 183d
Cleared Dec 21, 2021
TheraFace LED
K212155 · OHS
Theragun, Inc.
General & Plastic Surgery · 162d