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
Fusion FibFix Nail
Fusion Orthopedics USA, LLC
Synthes Patient Specific Implants
Synthes GmbH
Velacur
Sonic Incytes
Lyra Influenza A+B Assay
Quidel Corporation
Resonic Rapid Acoustic Pulse Device
Soliton, Inc.
MV Flow Aspiration Pump (MVFLOWPMP01)
Microvention
Hand-held IPL device (JOVS Hair Removal Device)
Shenzhen Qianyu Technology Co., Ltd.
MOBINEURO Alita Intraoperative MRI System
Sino Canada Health Engineering Research Institute (Hefei)
BriefCase-Quantification
Aidoc Medical , Ltd.
Microthin Natural Rubber Latex Condom
Suretex Limited
ASTar BC G- Kit and ASTar Instrument
Q-Linea AB
NeckTune SA Cervical Cage
Medyssey Co., Ltd.
LISA Laser Surgical Fibers
Omni-Guide Holdings, Inc.
Lorals
Brazen Goods Inc. Dba Lorals
DuraPro Oscillating System
Globus Medical, Inc.
HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx
Qingdao Hightop Biotech Co., Ltd.
Momcozy Nasal Aspirator (BN007)
Shenzhen Root Innovation Technology Co., Ltd.
BruxZir TintEFX Coloring Liquid
Prismatik Dentalcraft, Inc.
Fiber Laser Treatment Systems (HS-232,HS-233)
Shanghai Apolo Medical Technology Co., Ltd.
Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture
Teleflex Medical, LLC
Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SH
Shokz Health Global Limited
Wearable Breast Pump (Model S33)
Shenzhen TPH Technology Co., Ltd.
Enteral Feeding Set
Kb Medical (Group), Inc.
Solution Administration Sets
Baxter Healthcare Corporation
Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V
Remex Medical Corporation
PELNAC Meshed Bilayer Wound Matrix
Gunze Limited
Yumizen H2500
HORIBA ABX SAS
Fitness Belt (Model: KLT-07)
Shenzhen Kelutongda Industrial Co., Ltd.
Ice Cooling IPL Hair Removal Device (UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI
Shenzhen Ulike Smart Electronics Co., Ltd.
InZone IST Detachment System; IZDS Connecting Cable
Stryker Neurovascular
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