510(k) Device Clearances
Medical devices cleared through the FDA's 510(k) premarket notification process. Substantially equivalent to existing devices.
15,000 total clearances
MyShoulder Planner (5.3SSWPL)
Medacta International S.A.
Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3)
Foshan Nanhai Plus Medical Co, Ltd.
Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim
Eco Medi Glove Sdn. Bhd.
ASAHI Gladius Mongo18 PV ES
Asahi Intecc Co., Ltd.
KLS Martin Pure Pectus System
KLS Martin L.P.
ELLAVI UBT
Sinapi Biomedical (Pty) , Ltd.
Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
GE Medical Systems Ultrasound and Primary Care Diagnostics
TDM Anterior Cervical Plate System
Tdm Co., Ltd.
Picosecond Nd:YAG Laser System
Smedtrum Medical Technology Co., Ltd.
Dentca Base Premium, Dentca Base Hi-Impact
Dentca, Inc.
3DICOM MD Cloud
Singular Health Pty, Ltd.
Dose IQ Safety Software
Baxter Healthcare Corporation
Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard
Unibeauty (Hubei) Technology Co., Ltd.
ANNE One
Sibel Health, Inc.
Infrared thermometer
Shenzhen Yolanda Technology Co., Ltd.
CeraPutty
Meta Biomed Co., Ltd.
Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020)
Intervene
Denture Base Resin
Aidite (Qinhuangdao) Technology Co., Ltd.
Bendit17 Microcatheter
Bend IT Technologies, Ltd.
Us2.v1
Eko.Ai Pte Ltd. D/B/A Us2.Ai
Definium Pace Select ET
Ge Hualun Medical Systems Co. , Ltd.
NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)
Synaptic Medical Corporation
BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App
Bd Kiestra B.V.
VersaCross Connect Transseptal Dilator
Baylis Medical Company, Inc.
Zavation eZspand Interbody System
Zavation Medical Products, LLC
VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-
bioMerieux, Inc.
SECURE-LOCK
Xiros, Ltd.
Amethyst HP PTA OTW 0.035 Catheter
Natec Medical , Ltd.
Luminopia One
Luminopia, Inc.
Evenflo Premium Double Electric Breast Pump (Model 4018)
Evenflo Feeding, Inc.
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