Search FDA 510(k) Database

6,787 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
13681–13704 of 174,061
Cleared Dec 15, 2021
Serranator PTA Serration Balloon Catheter
K213728 · PNO
Cagent Vascular, LLC
Cardiovascular · 19d
Cleared Dec 14, 2021
Blood Collection Needles
K200932 · FMI
Vacutest Kima Srl
General Hospital · 616d
Cleared Dec 14, 2021
S2 Pigment Removal System
K202848 · GEX
Lightsense Technologies, Ltd.
General & Plastic Surgery · 445d
Cleared Dec 14, 2021
PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use...
K203716 · QFC
Smith and Nephew Medical Limited
General & Plastic Surgery · 358d
Cleared Dec 14, 2021
Instant 20s Indicator
K210481 · MTC
True Indicating, LLC
General & Plastic Surgery · 298d
Cleared Dec 14, 2021
Surgical Mask
K210744 · FXX
Chongqing PA Xijia Biotechnology Co.,...
General Hospital · 277d
Cleared Dec 14, 2021
ZEPTO Precision Capsulotomy System
K210827 · PUL
Centricity Vision, Inc.
Ophthalmic · 270d
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