Search FDA 510(k) Database

6,459 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
8473–8496 of 174,061
Cleared Aug 03, 2023
Sterile Water for Inhalation in 1L Flexoval ® bottles.
K223551 · BTT
Hometa, Inc.
Anesthesiology · 251d
Cleared Aug 03, 2023
TubaVent Balloon Dilatation System
K223542 · PNZ
Spiggle & Theis Medizintechnik GmbH
Ear, Nose, Throat · 251d
Cleared Aug 03, 2023
VisiRad XR
K223133 · MYN
Imidex, Inc.
Radiology · 304d
Cleared Aug 03, 2023
MENIX®
K223122 · GAT
S.B.M. Sas (Science & Bio Materials)
General & Plastic Surgery · 304d
Cleared Aug 03, 2023
Lumbar Expandable lnterbody Spacers -Additional Indications/Implants
K221894 · MAX
Globus Medical, Inc.
Orthopedic · 399d
Cleared Aug 02, 2023
Ingenia Elition R5.7.1 SP4 MR Systems
K232030 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 26d
Cleared Aug 02, 2023
Mineral Collagen Composite Bioactive Extra Moldable
K231942 · MQV
Collagen Matrix, Inc.
Orthopedic · 33d
Cleared Aug 02, 2023
Sapphire X3 Anterior Cervical Plate System
K231593 · KWQ
Spinal Elements, Inc.
Orthopedic · 62d
Cleared Aug 02, 2023
ActivSight Intraoperative Imaging System
K231344 · OWN
Activ Surgical, Inc.
General & Plastic Surgery · 85d
Cleared Aug 02, 2023
Chemfort® Catheter Adaptor
K231286 · ONB
Simplivia Healthcare , Ltd.
General Hospital · 90d
Cleared Aug 02, 2023
BPBIO750
K231174 · DXN
Inbody Co., Ltd.
Cardiovascular · 99d
Cleared Aug 02, 2023
Eblator Device
K231126 · GEI
E Surgical, LLC
General & Plastic Surgery · 104d
Cleared Aug 02, 2023
Disposable Ureteral Access Sheath
K230748 · FED
Youcare Technology Co.,Ltd. (Wuhan)
Gastroenterology & Urology · 138d
Cleared Aug 02, 2023
SKEEPER
K230613 · DQD
Smartsound Corporation
Cardiovascular · 149d
Cleared Aug 02, 2023
Self-Cath Closed System
K223821 · FCM
Coloplast
Gastroenterology & Urology · 224d
Cleared Aug 02, 2023
Disposable Needle Guides and Grids
K223689 · ITX
Advance Medical Designs, Inc.
Radiology · 236d
Cleared Aug 02, 2023
Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine
K223553 · OLO
Brainlab AG
Orthopedic · 250d
Cleared Aug 02, 2023
Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors
K223114 · MBI
Gm Dos Reis Industria E Comerico Ltda.
Orthopedic · 303d
Cleared Aug 02, 2023
Immunoglobulin G (IgG)
K221114 · CFN
Beckman Coulter Laboratory Systems...
Immunology · 474d
Cleared Aug 01, 2023
REAL INTELLIGENCE™ CORI™
K231963 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 29d
Cleared Aug 01, 2023
EXPD 4357
K231959 · MQB
DRTECH Corporation
Radiology · 29d
Cleared Aug 01, 2023
Aristotle 18 Guidewire
K231954 · MOF
Scientia Vascular, Inc.
Neurology · 29d
Cleared Aug 01, 2023
Nuubo Smart
K231620 · DQK
Smart Solutions Technologies SL
Cardiovascular · 60d
Cleared Aug 01, 2023
Protego Air Water Connector
K231602 · OCX
Ga Health Company Limited
Gastroenterology & Urology · 61d