Search FDA 510(k) Devices

5,777 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
4369–4392 of 174,061
Cleared Nov 15, 2024
EchoGo Amyloidosis (1.0)
K240860 · SDJ
Ultromics Limited
Cardiovascular · 232d
Cleared Nov 15, 2024
b-ONE® Total Hip System
K240528 · LZO
B-One Ortho, Corp.
Orthopedic · 266d
Cleared Nov 15, 2024
VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G),...
K240523 · MQE
Shenzhen Vitavitro Biotech Co., Ltd.
Obstetrics & Gynecology · 266d
Cleared Nov 15, 2024
NUVENTUS NV.C™ Dental Implant System
K233081 · DZE
Infinitum Eta, Ltd.
Dental · 416d
Cleared Nov 14, 2024
Xrecovery (XR-001)
K242940 · IRP
Shenzhen Xinrun Electric Appliances...
Physical Medicine · 50d
Cleared Nov 14, 2024
Tandry Q-Locking Plate System
K242814 · HRS
Microware Precision Co., Ltd.
Orthopedic · 57d
Cleared Nov 14, 2024
DEFINE System (AG612444A)
K242598 · PBX
Inmode , Ltd.
General & Plastic Surgery · 76d
Cleared Nov 14, 2024
Intense Pulsed Light Treatment System (LK-PT)
K242440 · ONF
Nanjing Bestview Laser S&T Co., Ltd.
General & Plastic Surgery · 90d
Cleared Nov 14, 2024
Proximal Humerus Fixation System
K242436 · HRS
Skeletal Dynamics, Inc.
Orthopedic · 90d
Cleared Nov 14, 2024
Fetal EchoScan
K242342 · POK
Brightheart
Radiology · 99d
Cleared Nov 14, 2024
Arthrex Elbow Fracture Plating System
K242079 · HRS
Arthrex, Inc.
Orthopedic · 121d
Cleared Nov 14, 2024
Veincare
K241930 · GEX
Wontech Co., Ltd.
General & Plastic Surgery · 136d
Cleared Nov 14, 2024
Hinscope
K241397 · MSX
Hinlab Sas
Cardiovascular · 182d
Cleared Nov 14, 2024
Besmed Bacterial Filter and HMEF
K241339 · CAH
Besmed Health Business Corp
General Hospital · 185d
Cleared Nov 13, 2024
CeQur Simplicity™ On-Demand Insulin Delivery System
K243273 · OPP
Cequr SA
Chemistry · 28d
Cleared Nov 13, 2024
LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone...
K242856 · FRO
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 54d
Cleared Nov 13, 2024
MediRod Pedicle Screw System
K242764 · NKB
Cmf Medicon Surgical, Inc.
Orthopedic · 61d
Cleared Nov 13, 2024
Dental Glass Ceramics Blocks (HT, LT, MT)
K242407 · EIH
Hunan Vsmile Biotechnology Co., Ltd.
Dental · 91d
Cleared Nov 13, 2024
RESPOND(R) Ventilator
K241135 · CBK
Corvent Medical, Inc.
Anesthesiology · 203d
Cleared Nov 13, 2024
Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW,...
K240337 · EFB
Guangdong Jinme Medical Technology...
Dental · 282d
Cleared Nov 13, 2024
Nonin OTC Pulse Oximeter Model 3250
K211498 · OLK
Nonin Medical, Inc.
Anesthesiology · 1279d
Cleared Nov 12, 2024
Electric wheelchair (KR-8807)
K242791 · ITI
Zhejiang Kairui Medical Device Co., Ltd.
Physical Medicine · 57d
Cleared Nov 12, 2024
InPen System App (MMT-8060 (iOS), MMT-8061 (Android))
K242775 · NDC
Medtronic Minimed
Chemistry · 60d
Cleared Nov 12, 2024
Aurelia Surgical Mask ASTM Level-3 (2130)
K242502 · FXX
Supermax Healthcare Canada-Supermax...
General Hospital · 82d