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
TC Gloves
Thanh Cong Pharmaceutical and Trading Company Limited
AI-Rad Companion Brain MR
Siemens Healthcare GmbH
Air Pressure Foot Massager
Xiamen Simo Electronic Co., Ltd.
syngo Dynamics (Version VA41D)
Siemens Healthcare GmbH
Arthrex Mini Fragment System
Arthrex, Inc.
Sclerotherapy & Endoscopic Needles
G-Flex Europe Sprl
Steriking® LT-Blueline Pouches with Tyvek®
Wipak OY
CO2 Laser Therapy System (Model: LFS-D9U)
Sanhe Lefis Electronics Co., Ltd.
TopCEM Dual Cure Resin Cement
Rizhao Huge Biomaterials Company, Ltd.
NeoNavia Biopsy System
Neodynamics AB
B4C System
Braincare Desenvolvimento E Inovacao Tecnologica S.A.
Myoaligner Appliance
Myohealth Technologies, LLC
C.C. Life 21
21 Equipment S.R.L.
Modius Lean
Neurovalens Limited
StrataMR II Valves and Shunts
Medtronic Neurosurgery
DeepRhythmAI
Medicalgorithmics S.A.
PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)
Primus Sterilizer Company, LLC
Immunoglobulin G (IgG)
Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.
Rotarex Atherectomy System
Bard Peripheral Vascular, Inc.
XENOVIEW 3.0T Chest Coil
Polarean, Inc.
Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)
Zhuhai Pusen Medical Technology Co., Ltd.
ANNE Maternal
Sibel Health, Inc.
Rapid LVO
Ischemaview, Inc.
RESPONSE 5.5/6.0 Cannulated Screw System
OrthoPediatrics Corp.
CELERITY 20 HP Challenge Pack
Steris
da Vinci SP Instruments (SP1098)
Intuitive Surgical, Inc.
Tablo Cartridge
Outset Medical, Inc.
AeviceMD
Aevice Health Pte. , Ltd.
PM2+ System and SmartPICC Stylet
Piccolo Medical, Inc.
Monoject Enteral Syringe with ENFit Connector (401SE); Monoject Enteral Syringe with ENFit Connector (403SE); Monoject
Cardinalhealth
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