Search FDA 510(k) Database

6,454 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
8401–8424 of 174,061
Cleared Aug 11, 2023
Carex Hybrid Personal Lubricant
K223519 · NUC
Karex Industries Sdn. Bhd.
Obstetrics & Gynecology · 261d
Cleared Aug 11, 2023
Otsuka Digital Feedback Device-RW
K223463 · OZW
Otsuka America Pharmaceutical, Inc.
Cardiovascular · 268d
Cleared Aug 11, 2023
BlueStar CGM insulin dose calculator
K222888 · QRX
Welldoc, Inc.
Chemistry · 322d
Cleared Aug 10, 2023
Aura 10 PET/CT
K231420 · QXL
Xeos Medical
Radiology · 86d
Cleared Aug 10, 2023
EnSite™ X EP System
K231415 · DQK
Abbott Medical
Cardiovascular · 86d
Cleared Aug 10, 2023
AirLife DuoTherm™ Humidification System
K231380 · BTT
Vyaire Medical, Inc.
Anesthesiology · 90d
Cleared Aug 10, 2023
ReliOn Premier BLU Blood Glucose Monitoring System
K230625 · NBW
I-Sens, Inc.
Chemistry · 157d
Cleared Aug 10, 2023
Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2
K230428 · EOQ
Ambu A/S
Ear, Nose, Throat · 174d
Cleared Aug 10, 2023
ZenPro 40
K230268 · GEX
BLUECORE COMPANY Co., Ltd.
General & Plastic Surgery · 191d
Cleared Aug 10, 2023
ANNE One
K223711 · DRG
Sibel Health, Inc.
Cardiovascular · 241d
Cleared Aug 10, 2023
GEM Premier 7000 with IQM3
K223608 · CHL
Instrumentation Laboratory Company
Chemistry · 251d
Cleared Aug 10, 2023
SuperBall Meniscal Repair System
K223500 · GAT
Arcuro Medical , Ltd.
General & Plastic Surgery · 262d
Cleared Aug 10, 2023
ArtiFascia
K223445 · GXQ
Nurami Medical , Ltd.
Neurology · 269d
Cleared Aug 10, 2023
HAVAb IgG II
K222850 · LOL
Abbott Laboratories
Microbiology · 323d
Cleared Aug 10, 2023
ID NOW COVID-19 2.0
K221925 · QWR
Abbott Diagnostics Scarborough, Inc.
Microbiology · 405d
Cleared Aug 10, 2023
Accu-Chek Solo micropump system with interoperable technology
K213134 · QFG
Roche Diabetes Care GmbH
Chemistry · 682d
Cleared Aug 10, 2023
Accu-Chek Guide Solo diabetes manager blood glucose monitoring system
K213131 · NBW
Roche Diabetes Care GmbH
Chemistry · 682d
Cleared Aug 09, 2023
Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with...
K232039 · LZA
Grand Work Plastic Products Co., Ltd.
General Hospital · 30d
Cleared Aug 09, 2023
Medline UNITE® REFLEX® Nitinol Staple System
K231885 · JDR
Medline Industries, LP
Orthopedic · 43d
Cleared Aug 09, 2023
VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack
K231525 · NIG
Ortho-Clinical Diagnostics
Immunology · 75d
Cleared Aug 09, 2023
Intense Pulsed Light System
K231394 · ONF
Smedtrum Medical Technology Co., Ltd.
General & Plastic Surgery · 86d
Cleared Aug 09, 2023
Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles,...
K231376 · MBI
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared Aug 09, 2023
Conductive Silicone Rubber Electrode
K231167 · GXY
Guangzhou Xinbo Electronic Co., Ltd.
Neurology · 106d
Cleared Aug 09, 2023
Conductive carbon film electrode
K231164 · GXY
Guangzhou Xinbo Electronic Co., Ltd.
Neurology · 106d