Search FDA 510(k) Database

6,517 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
9385–9408 of 174,061
Cleared Apr 21, 2023
Knee+
K230789 · SBF
Pixee Medical
Orthopedic · 30d
Cleared Apr 21, 2023
Anatase Spine Surgery Navigation System
K230783 · OLO
Remex Medical Corp.
Orthopedic · 30d
Cleared Apr 21, 2023
EzDent Web
K230468 · LLZ
Ewoosoft Co., Ltd.
Radiology · 59d
Cleared Apr 21, 2023
HERA W10 Diagnostic Ultrasound System
K230084 · IYN
Samsung Medison Co., Ltd.
Radiology · 100d
Cleared Apr 21, 2023
ViewFinder Software Version 1.1
K223501 · QIH
Elaitra, Ltd.
Radiology · 151d
Cleared Apr 21, 2023
Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle,...
K223300 · KNW
Geotek Medikal Ltd Sti
General & Plastic Surgery · 176d
Cleared Apr 21, 2023
Modular Rotating Hinge Knee Systems and Compatible Components
K223069 · KRO
Howmedica Osteonics Corp., Dba...
Orthopedic · 203d
Cleared Apr 21, 2023
dentona flexisplint, optimill memosplint, dentona vivatemp, optimill...
K222604 · MQC
Dentona AG
Dental · 235d
Cleared Apr 21, 2023
Paradigm System
K222291 · OLO
Proprio, Inc.
Orthopedic · 263d
Cleared Apr 21, 2023
AEON Endoscopic Stapler
K222210 · GDW
Lexington Medical, Inc.
General & Plastic Surgery · 270d
Cleared Apr 21, 2023
CONNEQT PULSE
K221742 · DXN
Atcor Medical
Cardiovascular · 310d
Cleared Apr 21, 2023
Kyphoplasty Balloon System
K221142 · HRX
OK Medinet Korea Co., Ltd.
Orthopedic · 367d
Cleared Apr 20, 2023
Deep Learning Image Reconstruction
K230807 · JAK
Ge Healthcare Japan Corporation
Radiology · 28d
Cleared Apr 20, 2023
Precision1, Precision1 for Astigmatism
K230785 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 29d
Cleared Apr 20, 2023
HILINE™ Fixation System
K230565 · OWI
Globus Medical, Inc.
Orthopedic · 50d
Cleared Apr 20, 2023
RadiForce RX270
K223768 · PGY
Eizo Corporation
Radiology · 126d
Cleared Apr 20, 2023
Neodent Implant System - Helix Short Surgical Kit Cases
K223662 · KCT
Jjgc Industria E Comercio DE...
General Hospital · 135d
Cleared Apr 20, 2023
Velacur
K223287 · IYO
Sonic Incytes
Radiology · 177d
Cleared Apr 20, 2023
STARband 3D
K223238 · MVA
Orthomerica Products, Inc.
Neurology · 182d
Cleared Apr 20, 2023
Flexible Video-Choledochoscope System
K222261 · FBN
Shanghai SeeGen Photoelectric...
Gastroenterology & Urology · 266d
Cleared Apr 20, 2023
BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter,...
K222095 · QEY
Thrombolex, Inc.
Cardiovascular · 276d
Cleared Apr 20, 2023
SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe
K220981 · DWP
Fehling Surgical Instruments, Inc.
Cardiovascular · 381d
Cleared Apr 20, 2023
ArtFX Spinal Fixation System
K212220 · NKB
Artfx Medical, LLC
Orthopedic · 643d
Cleared Apr 20, 2023
Inomax DSIR
K211153 · MRN
Mallinckrodt Manufacturing, LLC
Anesthesiology · 731d