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
Miro3D Wound Matrix
Reprise Biomedical, Inc.
Wrist Blood Pressure Monitor
Zhuhai Yueja Medical Device Technology Co., Ltd.
Microstream CO2 NanoPod
Covidien, LLC
UltraScore Focused Force PTA Balloon
Bard Peripheral Vascular, Inc.
Diode Laser Therapy Device (DF-DIODE LASER-S1)
Weifang Dragonfly Electronics Technology Co., Ltd.
Velano Vascular Blood Collection Adapter
Velano Vascular
New Day Skin Spray
Silk Holdings, Inc.
PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)
Methyl Co., Ltd.
IPDmilled Blanks
Implant Protesis Dental 2004, S.L.
ProSeal In Line Pump Set (423850)
Epic Medical Pte. , Ltd.
Crossloop
Asahi Intecc Co., Ltd.
Single-Use Biopsy Valve (MAJ-1555)
Olympus Medical Systems Corporation
ONO Retrieval Device
Onocor Vascular, LLC
ZZIREN Orogastric Tube; ZZIREN SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN SGT Orogastric Tube - 36 Fr (ZZ-SGT-36
Tools For Surgery, LLC
ClearPoint System (Software Version 3.0)
ClearPoint Neuro, Inc.
CARTO® 3 EP Navigation System with CARTOSOUND 4D Version 7.4
Biosense Webster, Inc.
MIM LesionID Pro
Mim Software, Inc.
MDx-Chex for BC-GP
Streck
EzVu Visual Vasopressor injector (EV-19)
Veol Medical Technologies Pvt , Ltd.
Gas Insufflator
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
10THERMA
Tentech, Inc.
Ruthinium Disc
Dental Manufacturing S.p.A.
Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator
STERIS Corporation
Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line
Tigon Medical
HELIOS 785 Pico (1754V2)
Laseroptek Co., Ltd.
BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))
Biofire Diagnostics, LLC
SkyWalker Total Knee System
Microport Navibot International, LLC
CeraRoot TL Implant System (TL)
Ceraroot SL
OdneClean
Odne AG
SnapshotNIR model KD205
Kent Imaging, Inc.
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