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
DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System
DePuy Synthes
Adena-Zina System
Shanghai Sanyou Medical Co, Ltd.
BoneMRI v1.4
Mrlguidance B.V.
PeekMed web
Peek Health, S.A.
RedEx
Advanced Surgical Concepts, Ltd.
Cerebral Autoregulation Index (CAI) Algorithm
Edwards Lifesciences
Harmony Referral System with Harmony OCT Viewer (Octave)
Topcon Healthcare Solutions EMEA Oy
Acute QC Strut and Components
Smith & Nephew, Inc.
PRIMA TT Glenoid
Lima Corporate S.P.A.
Stratasys TrueDent
Stratasys, Ltd.
ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)
Instrumentation Laboratory (IL) Co.
IRRIGO Wound Wash Jet System
Inopro, Inc.
Portable oxygen concentrator (JAY-1000P)
Longfian Scitech Co., Ltd.
FLASH Facet Fusion Instruments, IsoTis® Facet Fusion Instruments
SeaSpine Orthopedics Corporation
FlowTriever2 Catheter
Inari Medical, Inc.
Butterfly iQ/iQ+ Ultrasound System
Butterfly Network, Inc.
Safety Sliding Blood Collection Set
Jiangsu Caina Medical Co.,Ltd
TruSPECT Processing Station
Spectrum Dynamics Medical, Ltd.
Digital thermometer, Model DT101, DT102
Guangzhou Berrcom Medical Device Co., Ltd.
EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)
Olympus Medical Systems Corp.
Rugged Oxygen Generator (ROG) (RO01-00001)
Molecular Products , Ltd.
MESI mTABLET SPIRO
Mesi D.O.O.
Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)
Zhuhai Wesee Meditech Co., Ltd.
EchoGo Heart Failure (2.0)
Ultromics Limited
Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System
Medacta International S.A.
PSX Interbody System
Alphatec Spine, Inc.
ISOLIS Cryoprobe
Varian Medical Systems, Inc.
StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2
Fona S.R.L
ARTICUL/EZE Ceramic Heads
Depuy Ireland UC
Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use
Sichuan Prius Biotechnology Co., Ltd.
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