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
StrataMR II Valves and Shunts
Medtronic Neurosurgery
coactiv+ Antimicrobial Wound Gel
Kane Biotech, Inc.
Stent Positioning Assistance System (SPAS)
Seven Sons , Ltd.
XSense Cryoablation System with CryoProbes
IceCure Medical , Ltd.
Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva
Poly Medicure Limited
SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module
Heidelberg Engineering GmbH
MagVenture TMS Atlas Neuro Navigation System
Tonica Elektronik A/S
DURAMESH Mesh Suture
Msi
OsteoCentric® UnifiMI® TCS Plating System
OsteoCentric Technologies
MAGIC Flow-Dependent Microcatheter
Balt USA, LLC
Amplatz Goose Neck Snare Kit
Medtronic, Inc.
Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)
Shanghai AnQing Medical Instrument Co., Ltd.
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
NObreath®
Bedfont Scientific, Ltd.
6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter
Medtronic Vascular
Biowy Tym Tube (TT)
Biowy Corporation
EQUIA LC ONE
GC America, Inc.
Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fenta
Mah Sing Healthcare Sdn. Bhd.
Access TPO Antibody
Beckman Coulter, Inc.
LARS ACJ
Movmedix S.A.S.
Pangea Utility Plating System, Pangea Platform
Stryker GmbH
Ultrast Gel
Ultrast, Inc.
CADDIE
Odin Medical Limited
KLS Martin IPS Forearm System
KLS-Martin L.P.
S-Patch Ex Wearable ECG Patch
Wellysis Corp.
Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)
Gigaalaser Company , Ltd.
Humask Pro Vision, Humask Pro Vision 3000
Entreprise Premont, Inc.
butterflyBVM
Compact Medical, Inc.
The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL
Thermo Fisher Scientific
U9000 Plus Ultrafilter
Baxter Healthcare Corporation
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