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
Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Conn
Cefaly Technology
FUBUKI XF-R Neurovascular Long Sheath
Asahi Intecc Co., Ltd.
PeekMed web
Peek Health, S.A.
C510G/JUSHA-C510G/C510/JUSHA- C510 LCD Monitor
Nanjing Jusha Display Technology Co., Ltd.
Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT
Healgen Scientific,, LLC
Biomet Kirschner Wires (K-Wires)
Biomet, Inc.
BriefCase-Triage
Aidoc Medical , Ltd.
Rezum System
Boston Scientific Corporation
ODI-Tech
Odi Medical AS
Newclip Patient-matched instrumentation non sterile PSI
Newclip Technics
CER-S
Cardiocalm Srl
Arthrex Beaming System
Arthrex, Inc.
Microcurrent device (Model: HBR2-1)
Shenzhen DJ Medical Equipment Co., Ltd.
Tulsa Pro System (Pad-105)
Profound Medical, Inc.
FP3D
Keystone Industries
ApolloHipX (THR.SS.0001)
Corin U.S.A. Limited
ANNE One
Sibel Health, Inc.
TriMed Compression Screws
TriMed, Inc.
ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0)
Medphoton GmbH
Statera-C Spinal System
K&J Consulting Corp.
Safety Lancet (XXXV)
Tianjin Huahong Technology Co., Ltd.
Multi-Parameter Patient Monitor
Shenzhen Comen Medical Instruments Co.,Ltd
FONA XDC
Fona S.R.L
Irrigation Tubing Bipolar Cord Set
New Deantronics Taiwan , Ltd.
aboNT SYRINGE
Nipro Medical Corporation
LOGIQ Focus
GE Medical Systems Ultrasound and Primary Care Diagnostics
FaceHeart Vitals Software Development Kit (FH vitals SDK)
Faceheart Corp.
E Blator
New Deantronics Taiwan , Ltd.
Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile
Berpu Medical Technology Co., Ltd.
XLO Brand of Locking Distal Humerus Plating System
Ortho Life Systems Private Limited
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