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
Small Volume 0.2mL Syringe
Prosum Medical Limited
Steam Sterilizer (2545D)
Ningbo Ican Machines Co., Ltd.
Orthoscan TAU Mini C-Arm
Ziehm-Orthoscan, Inc.
Viz SDH
Viz. Ai, Inc.
8MP Color LCD Displays C811W, C811WT, PA27 and PA27T
Shenzhen Beacon Display Technology Co., Ltd.
ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)
Sofradim Production
Oscar Peripheral Multifunctional Catheter system
Biotronik, Inc.
ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System
Spinecraft, LLC
CP Relief Wand Rx - TENS/NMES
N & C Holdings, LLC
Plus Medical Chemotherapy Gown
Foshan Nanhai Plus Medical Co, Ltd.
EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III
Olympus Medical Systems Corp.
ProtekDilate Vascular Access Kit
Sorin Group Italia S.R.L.
XC11 ICE System, USA
Yorlabs, Inc.
Digital Radiography System (ManntiX B, ManntiX K)
Shenzhen Browiner Tech Co., Ltd.
Omnifix Syringe NRFit
B.Braun Medical, Inc.
Dayspring Lite
Koya Medical, Inc.
VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
Specific Diagnostics, LLC
Disposable Extension Set
Shandong Ande Healthcare Apparatus Co., Ltd.
ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter
Silk Road Medical, Inc.
Nutrifit
Vygon USA
Aesculap Slim Clip Applier
Aesculap, Inc.
LUTRONIC GENIUS
Cynosure Lutronic Technology Corporation
Neowise
Cefla S.C.
Arthrex Virtual Implant Positioning (VIP) System
Arthrex, Inc.
Disposable Nitrile Examination Gloves (Powder free, Blue)
Leping Shengde Medical Technology Company Limited
HexaPLUS S OneDrill Implant System
Osseofuse International, Inc.
Blue Topaz Sacroiliac Screw System
Osseus Fusion Systems, LLC
Polyshield Safety IV Catheters
Poly Medicure Limited
HandPICO
Vydence Medical Industria E Comercio Ltda
SyMRI
Syntheticmr AB
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