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
Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00818)
Arrow International, LLC (A subsidiary of Teleflex, Inc.)
Non Absorbable Surgical Nylon Suture
Shandong Haidike Medical Product Co., Ltd.
Concha Sol Hearing Aids (CL-1001)
Concha Labs
Access hsTnI
Beckman Coulter, Inc.
EMPOWR Revision Knee (EMPOWR Revision VVC+, e+ Tibial Insert)
Encore Medical L.P.
Vassallo GT 018 Hybrid
Filmecc Co., Ltd.
ANTHEM® Fracture System
Globus Medical, Inc.
Electric Breast Pump, model: YM-8166
Guangdong Youmeng Electrical Technology Co., Ltd.
Surgical face mask
Sunsmed Protective Products , Ltd.
Venus BlissMAX
Venus Concept USA, Inc.
Physica System (Physica CR Porous Femoral components)
Lima Corporate S.P.A.
Zimed Distal Medial Tibial Plate and Screw System
Zimed Medikal
CoLink® & CoLag® Non-Sterile Screws
In2Bones USA, LLC
The Alma Soprano Titanium
Alma Lasers, Inc.
WoundExpress
Huntleigh Healthcare , Ltd.
Pulse Oximeter
Shenzhen Brav Electronic Technologies Co., Ltd.
Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor,
Jarmon Medical, LLC (Dba Legends Orthopedics)
ProGear® Surgical Mask with Oxafence®, Model AV82030
Prestige Ameritech
Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense
Baxter Healthcare Corproration
DeGen Impulse AM System
Degen Medical
Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusa
Unimed Medical Supplies, Inc.
AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub
Philips Medical Systems Nederland B.V.
Copper Foam Dressing (Prescription and OTC)
Roosin Medical Co., Ltd.
Unistik® ShieldLock, Unistik VacuFlip
Owen Mumford, Ltd.
RW-1
Mediott, Inc.
UltraScore Focused Force PTA Balloon
Bard Peripheral Vascular, Inc.
InSet Total Shoulder System
Shoulder Innovations, Inc.
OmniTom Elite
Neurologica Corporation, A Subsidiary of Samsung
CATALYSTEM Femoral Stems
Smith & Nephew, Inc.
qXR-BT
Qure.Ai Technologies
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