Search FDA 510(k) Database

6,555 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
10009–10032 of 174,061
Cleared Feb 13, 2023
AmeriWater MediQA Reverse Osmosis System (MSP3HF)
K223656 · FIP
AmeriWater, LLC
Gastroenterology & Urology · 69d
Cleared Feb 13, 2023
OIC Intramedullary Screw System
K223761 · HWC
Orthopaedic Implant Company
Orthopedic · 60d
Cleared Feb 13, 2023
Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software,...
K223767 · OLO
Stryker Leibinger GmbH & Co KG
Orthopedic · 60d
Cleared Feb 13, 2023
EMPOWR™ blade stem
K223779 · LPH
Encore Medical, LLC
Orthopedic · 59d
Cleared Feb 13, 2023
Rhino Non-sterile Powder-Free Nitrile Exam Glove – Periwinkle Color Tested...
K223859 · LZA
Rhino Health, Inc.
General Hospital · 52d
Cleared Feb 13, 2023
syngo.via View&GO VA40A
K230196 · LLZ
Siemens Healthcare GmbH
Radiology · 19d
Cleared Feb 13, 2023
ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select...
K230207 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 19d
Cleared Feb 12, 2023
SMILE
K213629 · QGL
Nu Eyne Co., Ltd.
Neurology · 452d
Cleared Feb 10, 2023
RENASYS™-WF White Foam NPWT Dressing Small
K213853 · OMP
Smith and Nephew Medical Limited
General & Plastic Surgery · 427d
Cleared Feb 10, 2023
SEJONG Surgical Gown Soft
K220435 · FYA
Sejong Healthcare Co., Ltd.
General Hospital · 361d
Cleared Feb 10, 2023
Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001)
K220657 · FLL
Zhejiang Rongsheng Industrial Co., Ltd.
General Hospital · 340d
Cleared Feb 10, 2023
ARTSMedia In Vitro Culture Medium (AM-IVC Medium)
K220715 · MQL
Artsmedia Denmark Aps
Obstetrics & Gynecology · 336d
Cleared Feb 10, 2023
DiLumen C1, EZ1 and Tool Mount
K221452 · FDF
Lumendi, LLC
Gastroenterology & Urology · 268d
Cleared Feb 10, 2023
PRIMUS Healthcare Sterilizer (Model PSS11-HC)
K221474 · FLE
Primus Sterilizer Company, LLC
General Hospital · 266d
Cleared Feb 10, 2023
Perifit
K221476 · HIR
X6 Innovations
Gastroenterology & Urology · 266d
Cleared Feb 10, 2023
Nitrile Examination Powder Free Glove, Blue Tested For Use With 32...
K222129 · LZA
Top Glove Medical (Thailand) Co., Ltd.
General Hospital · 207d
Cleared Feb 10, 2023
Glass Ceramics
K222513 · EIH
Yilink (Tianjin) Biotechnology Co., Ltd.
Dental · 175d
Cleared Feb 10, 2023
S90 Exp Series Digital Color Doppler Ultrasound System
K222596 · IYN
Sonoscape Medical Corp.
Radiology · 168d
Cleared Feb 10, 2023
Glass Ceramic
K223194 · EIH
Shenzhen Xiangtong Co., Ltd.
Dental · 120d
Cleared Feb 10, 2023
Safety Lancet
K223208 · FMK
Suzhou Zhenwu Medical Co., Ltd.
General & Plastic Surgery · 116d
Cleared Feb 10, 2023
Pro-Tx Endorectal Balloon (PROT-25)
K223249 · PCT
Dxtx Medical, Inc.
Radiology · 151d
Cleared Feb 10, 2023
Pisces™-SA STANDALONE ALIF Interbody System
K223413 · OVD
Osseus Fusion Systems
Orthopedic · 93d
Cleared Feb 10, 2023
MD.ai Viewer
K223425 · LLZ
Mdai, Inc.
Radiology · 88d
Cleared Feb 10, 2023
TELIGEN System Peripheral Motor Nerve Stimulation Indications
K223438 · PDQ
Medos International SARL
Neurology · 88d