Search FDA 510(k) Database

6,608 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
10825–10848 of 174,061
Cleared Nov 07, 2022
Attain Command + SureValve Delivery System, Attain Select II + SureValve...
K222873 · DQY
Medtronic
Cardiovascular · 46d
Cleared Nov 07, 2022
SafeSource Direct Blue Powder-Free Nitrile Exam Gloves
K222898 · LZA
Safesource Direct, LLC
General Hospital · 45d
Cleared Nov 07, 2022
Humeris® 135 Shoulder System
K222936 · PHX
Fx Shoulder USA, Inc.
Orthopedic · 42d
Cleared Nov 07, 2022
HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable
K223127 · DQK
Edwards Lifeciences, LLC
Cardiovascular · 35d
Cleared Nov 05, 2022
Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack
K202755 · QDZ
Diasorin Molecular, LLC
Microbiology · 775d
Cleared Nov 04, 2022
Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge
K201256 · DCK
Procise Diagnostics
Immunology · 907d
Cleared Nov 04, 2022
Medwell Technology Ltd Syringes, various sizes
K212764 · FMF
Medwell Technology, Ltd.
General Hospital · 430d
Cleared Nov 04, 2022
Humerus & Ulna System
K213108 · HRS
Auxein Medical Private Limited
Orthopedic · 406d
Cleared Nov 04, 2022
BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring...
K220421 · NBW
Apex BioTechnology Corp.
Chemistry · 263d
Cleared Nov 04, 2022
Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and...
K220833 · MAI
Acuitive Technologies, Inc.
Orthopedic · 227d
Cleared Nov 04, 2022
cobas HCV
K221007 · MZP
Roche Molecular Systems, Inc.
Microbiology · 213d
Cleared Nov 04, 2022
CryoRobot Select System
K221086 · QUJ
Tmrw Life Sciences, Inc.
Obstetrics & Gynecology · 205d
Cleared Nov 04, 2022
UniVy OsteoVy Cervical IBF System
K221162 · ODP
Vy Spine, LLC
Orthopedic · 196d
Cleared Nov 04, 2022
Nextra CH Cannulated Hammertoe System
K221610 · HWC
Nextremity Solutions, Inc.
Orthopedic · 154d
Cleared Nov 04, 2022
Luminopia One
K221659 · QQU
Luminopia, Inc.
Ophthalmic · 149d
Cleared Nov 04, 2022
United U2 femoral head, 22mm delta ceramic head
K221675 · LPH
United Orthopedic Corporation
Orthopedic · 148d
Cleared Nov 04, 2022
BENCHMARK BMX81 Access System
K221822 · QJP
Penumbra, Inc.
Neurology · 134d
Cleared Nov 04, 2022
Yomi Robotic System
K222049 · QRY
Neocis, Inc.
Dental · 115d
Cleared Nov 04, 2022
Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle
K222124 · FMI
Anhui Hongyu Wuzhou Medical...
General Hospital · 109d
Cleared Nov 04, 2022
Self-adhesive Electrode
K222453 · GXY
Guangdong Comytens Medical Technology...
Neurology · 81d
Cleared Nov 04, 2022
VHA Radiotherapy Bolus
K222639 · IXI
Vha Dean
Radiology · 64d
Cleared Nov 04, 2022
Disposable Medical Face Mask (DF3-001)
K222697 · FXX
Wellmed Dental Medical Supply Co., Ltd.
General Hospital · 58d
Cleared Nov 04, 2022
World Total Knee System
K223062 · JWH
Signature Orthopaedics Pty, Ltd.
Orthopedic · 35d
Cleared Nov 04, 2022
Aquilo Sports CCT1500 System
K223164 · IRP
Aquilo Sports, LLC
Neurology · 28d