FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
14857–14880 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 14, 2021
DESS Dental Implants
K212538 · DZE
Terrats Medical SL
Dental · 124d
Cleared Dec 14, 2021
Surgical Face Mask
K212574 · FXX
Xiantao Deming Healthcare Products...
General Hospital · 120d
Cleared Dec 14, 2021
Aspira Peritoneal Drainage System
K212675 · PNG
Merit Medical Systems, Inc.
Gastroenterology & Urology · 112d
Cleared Dec 14, 2021
TimeWaver Frequency
K212832 · IPF
Timewaver Production GmbH
Physical Medicine · 98d
Cleared Dec 14, 2021
SeaSpine WaveForm C Interbody System
K212904 · OVE
SeaSpine Orthopedics Corporation
Orthopedic · 92d
Cleared Dec 14, 2021
MRIdian Linac System
K212958 · IYE
Viewray, Incorporated
Radiology · 89d
Cleared Dec 14, 2021
Nitrile Examination Gloves (Powder free, Blue)
K213029 · LZA
Weihai Hongyu Nonwoven Fabric...
General Hospital · 84d
Cleared Dec 14, 2021
EkoSonic Endovascular Device, EKOS+ Endovascular Device
K213422 · QEY
Boston Scientific Corporation
Cardiovascular · 55d
Cleared Dec 13, 2021
Surgical face mask: F-Y1-A
K202794 · FXX
Jiande Chaomei Daily Chemicals Co., Ltd.
General Hospital · 446d
Cleared Dec 13, 2021
Non Sterile Nitrile Powder Free Examination Gloves – Blue, Green and Black color
K210388 · LZA
Mexpo International, Inc.
General Hospital · 307d
Cleared Dec 13, 2021
Aesculap Slim Clip Applier
K211572 · HCI
Aesculap, Inc.
Neurology · 206d
Cleared Dec 13, 2021
Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)
K211942 · NGX
Shenzhen Osto Technology Company Limited
Physical Medicine · 173d
Cleared Dec 13, 2021
neXus Ultrasonic Surgical Aspirator System
K212060 · LFL
Misonix, Inc.
General & Plastic Surgery · 165d
Cleared Dec 13, 2021
Philips Radiology Smart Assistant
K212186 · KPR
Philips Medical Systems Dmc GmbH
Radiology · 153d
Cleared Dec 13, 2021
Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800...
K212221 · DHA
Diazyme Laboratories, Inc.
Chemistry · 150d
Cleared Dec 13, 2021
Centerpiece Plate Fixation System
K212428 · NQW
Medtronic Sofamor Danek
Orthopedic · 131d
Cleared Dec 13, 2021
SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard
K212706 · OBR
Splintek, Inc.
Dental · 109d
Cleared Dec 13, 2021
Disposable Surgical Gown, Disposable Reinforced Surgical Gown
K212869 · FYA
Fugou County Shenxiang Manufacturing...
General Hospital · 95d
Cleared Dec 13, 2021
Nyquist.IQ
K212890 · JAA
Omega Medical Imaging, LLC
Radiology · 94d
Cleared Dec 13, 2021
Heat StimPlus
K212918 · NUH
Famidoc Technology Co., Ltd.
Neurology · 90d
Cleared Dec 13, 2021
Nitrile Examination Gloves
K212924 · LZA
Shanxi Nacosa Medical Technology Co.,Ltd
General Hospital · 90d
Cleared Dec 13, 2021
Disposable Surgical Gown
K212925 · FYA
Henan Robestain Medical Products Co.,...
General Hospital · 90d
Cleared Dec 13, 2021
CoLink NeoFuse Plating System
K213069 · HRS
In2bones USA, LLC
Orthopedic · 81d
Cleared Dec 13, 2021
Disposable Nitrile Powder-Free Examination Gloves
K213176 · LZA
Anhui Zhong Lian Latex Gloves...
General Hospital · 76d