Search FDA 510(k) Database

7,155 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
22201–22224 of 174,061
Cleared Jan 11, 2019
SLEEPAPP
K182202 · LRK
Comfort Acrylics, Inc.
Dental · 150d
Cleared Jan 11, 2019
Geo Staple System
K182212 · JDR
Gramercy Extremity Orthopedics, LLC
Orthopedic · 149d
Cleared Jan 11, 2019
Applied Tissue Technologies PWD™ Platform Wound Dressing
K182409 · OMP
Applied Tissue Technologies, LLC
General & Plastic Surgery · 129d
Cleared Jan 11, 2019
Senhance Ultrasonic System
K182421 · NAY
Transenterix, Inc.
General & Plastic Surgery · 128d
Cleared Jan 11, 2019
ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)
K182453 · NUV
I-Tech Industries Srl
General & Plastic Surgery · 126d
Cleared Jan 11, 2019
Catalyst CSR Press-Fit Humeral Components
K182500 · KWT
Catalyst Orthoscience, Inc.
Orthopedic · 121d
Cleared Jan 11, 2019
MULTIX Impact
K182517 · KPR
Siemens Medi Cal Solutions, Inc.
Radiology · 120d
Cleared Jan 11, 2019
Tamper Evident Cap with Male Luer Lock
K182545 · FPA
International Medical Industries, Inc.
General Hospital · 116d
Cleared Jan 11, 2019
CD Horizon™ Spinal System
K182928 · NQP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 81d
Cleared Jan 11, 2019
DigitalDiagnost C90
K182973 · MQB
Philips Medical Systems Dmc GmbH
Radiology · 77d
Cleared Jan 11, 2019
ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)
K183031 · JWY
Biomerieux S.A.
Microbiology · 71d
Cleared Jan 11, 2019
uMR 580, uMR 588
K183137 · LNH
Shanghai United Imaging Healthcare...
Radiology · 59d
Cleared Jan 11, 2019
MTS Tetracycline 0.016 - 256 ug/mL
K183140 · JWY
Liofilchem S. R. L.
Microbiology · 59d
Cleared Jan 11, 2019
CereLink ICP Monitor, CereLink ICP Extension Cable
K183406 · GWM
Integra Lifesciences Corp.
Neurology · 32d
Cleared Jan 11, 2019
Roadrunner Extra Support Wire Guide
K183467 · DQX
Cook Incorporated
Cardiovascular · 28d
Cleared Jan 10, 2019
Advocate Non-Contact Infrared Thermometer
K180355 · FLL
Broadmaster Biotech, Corp.
General Hospital · 336d
Cleared Jan 10, 2019
Infrared Ear Thermometer
K180387 · FLL
Hetaida Technology Co., Ltd.
General Hospital · 332d
Cleared Jan 10, 2019
CONTEC Oxygen Concentrator
K180837 · CAW
Contec Medical System Co., Ltd.
Anesthesiology · 286d
Cleared Jan 10, 2019
OSSIO™ Pin Product Family
K181180 · HTY
OSSIO , Ltd.
Orthopedic · 253d
Cleared Jan 10, 2019
RENASYS Y-Connector
K181204 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 248d
Cleared Jan 10, 2019
CLARUS
K181444 · QER
Carl Zeiss Meditec, Inc.
Ophthalmic · 223d
Cleared Jan 10, 2019
Maxpower Relief
K182120 · NUH
Omron Healthcare, Inc.
Neurology · 157d
Cleared Jan 10, 2019
DIASAFEplusUS
K182367 · FIP
Fresenius Medical Care Renal...
Gastroenterology & Urology · 132d
Cleared Jan 10, 2019
Signal Catheter
K182635 · EZL
Safe Medical Design
Gastroenterology & Urology · 108d