Search FDA 510(k) Database

6,550 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
9913–9936 of 174,061
Cleared Feb 23, 2023
MOSAIQ® OIS (Oncology Information System)
K223229 · IYE
Elekta Solutions AB
Radiology · 128d
Cleared Feb 23, 2023
Symphony Thrombectomy System
K223216 · QEW
Truvic Medical, Inc.
Cardiovascular · 129d
Cleared Feb 23, 2023
Elekta Unity
K223209 · IYE
Elekta Solutions AB
Radiology · 129d
Cleared Feb 23, 2023
OXY-1 System
K223161 · DTZ
Abiomed, Inc.
Cardiovascular · 139d
Cleared Feb 23, 2023
Belun Sleep System BLS-100
K222579 · MNR
Belun Technology Company Limited
Anesthesiology · 182d
Cleared Feb 23, 2023
Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic...
K221591 · GCJ
Schoelly Fiberoptic GmbH
General & Plastic Surgery · 266d
Cleared Feb 23, 2023
Brainomix 360 e-ASPECTS
K221564 · POK
Brainomix Limited
Radiology · 268d
Cleared Feb 23, 2023
Disposable Surgical Gown, Level 4
K221559 · FYA
Stringking
General Hospital · 268d
Cleared Feb 23, 2023
Everion+ System
K213863 · MSX
Biofourmis Singapore Pte., Ltd.
Cardiovascular · 440d
Cleared Feb 22, 2023
The Alma Soprano Titanium
K230371 · GEX
Alma Lasers, Inc.
General & Plastic Surgery · 9d
Cleared Feb 22, 2023
Swoop® Portable MR Imaging System™
K230208 · LNH
Hyperfine, Inc.
Radiology · 28d
Cleared Feb 22, 2023
Disposable Pre-calibrated Brain Biopsy Needle 2.0
K230201 · HAW
PAJUNK GmbH Medizintechnologie
Neurology · 28d
Cleared Feb 22, 2023
BoneMRI v1.6
K230197 · QIH
Mriguidance B.V.
Radiology · 28d
Cleared Feb 22, 2023
Rosa Knee System
K230180 · OLO
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 30d
Cleared Feb 22, 2023
eFOLDi Scooter, Lite
K223492 · INI
Suntech UK , Ltd.
Physical Medicine · 93d
Cleared Feb 22, 2023
Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)
K223298 · LYY
Shandong Intco Medical Products Co, Ltd.
General Hospital · 118d
Cleared Feb 22, 2023
Delta III Pro
K221903 · LNS
Dornier Medtech America, Inc.
Gastroenterology & Urology · 237d
Cleared Feb 22, 2023
TRAUS Air Dental Handpiece
K221741 · EFB
Saeshin Precision Co., Ltd.
Dental · 252d
Cleared Feb 22, 2023
Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters)
K221629 · GAG
Covidien
General & Plastic Surgery · 261d
Cleared Feb 22, 2023
PATI (Protector Against Tongue Injury)
K221469 · JXL
Neurovice, LLC
Neurology · 278d
Cleared Feb 22, 2023
Eyer Retinal Camera NM-STD
K221329 · HKI
Phelcom Technologies
Ophthalmic · 292d
Cleared Feb 22, 2023
3D-RD-S
K212587 · IYX
Radiopharmaceutical Imaging and...
Radiology · 555d
Cleared Feb 21, 2023
Verifine® Ease Lancing Device, Verifine® Lancing Device
K223643 · QRL
Promisemed Hangzhou Meditech Co., Ltd.
General & Plastic Surgery · 77d
Cleared Feb 21, 2023
Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)
K223612 · KNW
Ranfac Corporation
General & Plastic Surgery · 78d