Search FDA 510(k) Devices

5,552 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
3385–3408 of 174,061
Cleared Mar 12, 2025
ReWalk® 7 Personal Exoskeleton (50-20-0005)
K241822 · PHL
Rewalk Robotics Ltd. Dba Lifeward
Neurology · 261d
Cleared Mar 11, 2025
Arthrex TightRope Soft Button, RT
K250424 · MBI
Arthrex, Inc.
Orthopedic · 25d
Cleared Mar 11, 2025
iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D)
K250374 · HBE
Stryker Instruments
Neurology · 29d
Cleared Mar 11, 2025
RemunityPRO™ Pump for Remodulin® (treprostinil) Injection
K250357 · FRN
Deka Research & Development Corp.
General Hospital · 32d
Cleared Mar 11, 2025
Origin™ TT Stem
K243029 · LZO
Signature Orthopaedics Pty, Ltd.
Orthopedic · 165d
Cleared Mar 11, 2025
8mm Monopolar Curved Scissors (470179)
K242610 · QSM
Iconocare Health
General & Plastic Surgery · 189d
Cleared Mar 11, 2025
Better Diagnostics Caries Assist (BDCA) Version 1.0
K241725 · MYN
Better Diagnostics AI Corp.
Radiology · 270d
Cleared Mar 11, 2025
OutFlo Aortic Valve Dilatation Balloon Catheter
K241562 · OZT
Disa Medinotec
Cardiovascular · 284d
Cleared Mar 10, 2025
Wound Treatment System (VHT-200)
K250188 · KPJ
Vaporox, Inc.
General & Plastic Surgery · 47d
Cleared Mar 10, 2025
Alteon® HA Femoral Stems
K243839 · MEH
Exactech, Inc.
Orthopedic · 87d
Cleared Mar 10, 2025
Duet External Drainage and Monitoring System (EDMS)
K243676 · JXG
Medtronic Neurosurgery
Neurology · 103d
Cleared Mar 10, 2025
da Vinci SP SureForm 45 Staplers and Reloads (SP1098)
K243596 · GAG
Intuitive Surgical, Inc.
General & Plastic Surgery · 109d
Cleared Mar 10, 2025
Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter...
K243101 · OWQ
Surgical Instrument Service and...
Cardiovascular · 161d
Cleared Mar 10, 2025
AGILON® XO Shoulder Replacement System
K241944 · KWT
Implantcast GmbH
Orthopedic · 251d
Cleared Mar 07, 2025
Portable Wheelchair
K243970 · ITI
Intradin (Shanghai) Machinery Co., Ltd.
Physical Medicine · 74d
Cleared Mar 07, 2025
FRONT-LINE Field Sterilizer (FL135)
K243801 · FLE
Fort Defiance Industries, LLC
General Hospital · 86d
Cleared Mar 07, 2025
Orthex External Fixation System
K243798 · KTT
OrthoPediatrics Corp.
Orthopedic · 86d
Cleared Mar 07, 2025
APTUS Hand System
K243610 · HRS
Medartis AG
Orthopedic · 105d
Cleared Mar 07, 2025
Flexible Video-Choledochoscope (CHV-110J-U)
K243535 · FBN
Shanghai SeeGen Photoelectric...
Gastroenterology & Urology · 112d
Cleared Mar 07, 2025
EpiWatch Monitoring System
K243515 · POS
Epiwatch, Inc.
Neurology · 114d
Cleared Mar 07, 2025
Lelo Hex Lubricated Natural Rubber Latex Condom
K243421 · HIS
Lelo, Inc.
Obstetrics & Gynecology · 123d
Cleared Mar 07, 2025
Op.n(TM) Navigation
K242914 · OLO
Ecential Robotics
Orthopedic · 164d
Cleared Mar 07, 2025
SPINEART Navigation Instrument System
K242890 · OLO
Spineart SA
Orthopedic · 165d
Cleared Mar 07, 2025
CuffTrek
K242642 · BSK
Shanghai Longmann Tech Co., Ltd.
Anesthesiology · 185d