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
TERA HARZ CLEAR
Graphy, Inc.
SutureLoc Implant
Arthrex, Inc.
Vy Spine VyWasher Buttress System
Vy Spine, LLC
Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); P
Nanjing Yinuoji Medical Technology Co., Ltd.
Romero Cervical Cage
Spineup, Inc.
SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing S
STERIS Corporation
Pristine Arthroscopic Visualization System
Pristine Surgical
Dermalage
Infection Elimination Solutions, LLC
Mpact® 3D Metal Implants - DMLS Technology
Medacta International S.A.
Dashboard (P007000)
Hill-Rom, Inc.
6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)
Esaote, S.p.A.
miCOR System Lens Fragmentation System
Carl Zeiss Meditec Cataract Technology, Inc.
Vial Adapter
Hangzhou Qiantang Longyue Biotechnology Co., Ltd.
Microwave Ablation Antennas
Canyon Medical, Inc.
Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl
Encompass Industries Sdn. Bhd.
TRIGEN META-TAN Trochanteric Antegrade Nail
Smith & Nephew, Inc.
Apollo TMS Therapy System;Apollo light TMS Therapy System
Mag & More GmbH
Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-)
Shenzhen Root Innovation Technology Co., Ltd.
Excelsior
Merit Cro, Inc.
SPECTRA Wearable 2
Uzinmedicare Co., Ltd.
AcuityUDR
Radmedix, LLC
CARTO 3 EP Navigation System Version 7.2
Biosense Webster, Inc.
INDEX BPM
Ya Horng Electronic Co., Ltd.
Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50
Thermo Fisher Scientific (Oxoid Ltd.)
LineSider® Spinal System
Integrity Implants, Inc.
Virgo Mobility Scooter (Virgo-D,Virgo-F)
Jiangsu Intco Medical Products Co., Ltd.
ART-Plan
Therapanacea
EndyMed PRO MAX
Endymed Medical, Ltd.
Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)
Xiamen Probtain Medical Technology Co., Ltd.
PROMO
DRGEM Corporation
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