Search FDA 510(k) Devices

5,565 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
3601–3624 of 174,061
Cleared Feb 12, 2025
OptoMonitor 3
K241418 · DXO
Opsens, Inc.
Cardiovascular · 268d
Cleared Feb 11, 2025
InbellaBody System
K250200 · GEI
Inbella Medical, Inc.
General & Plastic Surgery · 19d
Cleared Feb 11, 2025
Vivid T9/Vivid T8
K243628 · IYN
GE Medical Systems Ultrasound and...
Radiology · 78d
Cleared Feb 11, 2025
Vivid iq
K243620 · IYN
GE Medical Systems Ultrasound and...
Radiology · 81d
Cleared Feb 11, 2025
BinaxNOW™ COVID-19 Antigen Self Test
K243518 · QYT
Abbott Diagnostics Scarborough, Inc.
Microbiology · 90d
Cleared Feb 11, 2025
NUVENTUS NV.C™ Surgical Cassette and Tray
K243317 · KCT
Infinitum Eta, Ltd.
General Hospital · 112d
Cleared Feb 11, 2025
CYLOX® ST
K243188 · OVE
Signus Medizintechnik GmbH
Orthopedic · 134d
Cleared Feb 11, 2025
Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02,...
K243155 · FGB
Dongguan Zsr Biomedical Technology...
Gastroenterology & Urology · 134d
Cleared Feb 11, 2025
MOR
K241897 · QRC
Morari, Inc.
Gastroenterology & Urology · 228d
Cleared Feb 11, 2025
InSet Total Shoulder System
K241817 · KWT
Shoulder Innovations, Inc.
Orthopedic · 232d
Cleared Feb 11, 2025
Wrist Blood Pressure Monitor (XY-W01A, XY-W01B)
K241634 · DXN
Guangdong Xinyu Electronic and...
Cardiovascular · 250d
Cleared Feb 11, 2025
LONGY Implant and LONGY-N Implant
K241462 · DZE
Noris Medical , Ltd.
Dental · 264d
Cleared Feb 11, 2025
Rusch Endotracheal Tubes (Reinforced)
K241451 · BTR
Teleflex Incorporated
Anesthesiology · 265d
Cleared Feb 11, 2025
cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems
K240867 · QQX
Roche Molecular Systems, Inc.
Microbiology · 319d
Cleared Feb 10, 2025
Calcium2
K244042 · CJY
Abbott Ireland
Chemistry · 42d
Cleared Feb 10, 2025
Remi Custom Night Guard
K243516 · MQC
Grindguard, Inc.
Dental · 89d
Cleared Feb 10, 2025
OTC TENS & EMS Unit
K243511 · NGX
Changsha Anxiang Medical Technology...
Physical Medicine · 90d
Cleared Feb 10, 2025
Philips Lumea IPL
K243453 · OHT
Philips Consumer Lifestyle B.V.
General & Plastic Surgery · 95d
Cleared Feb 10, 2025
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae...
K243201 · JWY
Thermo Fisher Scientific
Microbiology · 132d
Cleared Feb 10, 2025
Myolight Microcurrent Handpiece
K243063 · NFO
Raja Trading Company, Inc.
Neurology · 136d
Cleared Feb 10, 2025
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae...
K242905 · JWY
Thermo Fisher Scientific
Microbiology · 139d
Cleared Feb 10, 2025
Ultrasound Workspace (UWS 6.0)
K241659 · QIH
Philips Ultrasound, LLC
Radiology · 245d
Cleared Feb 10, 2025
BTL-398
K241516 · KPI
BTL Industries, Inc.
Gastroenterology & Urology · 257d
Cleared Feb 10, 2025
Locking Plates and Screws Systems
K240958 · HRS
Hebei Ruihe Medical Devices Co., Ltd.
Orthopedic · 308d