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
X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application
Scopio Labs , Ltd.
Manual Wheelchair (7101L, 7102LHD)
Foshan Nanhai Hongchen Medical Equipment Co., Ltd.
Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Softwa
Ge Healthcare Information Technologies, Inc.
Rubber Utility Catheter
C.R. Bard, Inc.
Elite Biomedical Solutions Dose Request Cord
Elite Biomedical Solutions
Surgical Reality Viewer
Medicalvr B.V.
AerFrame Alignment Laser Box (LBV2)
Stabilix, LLC
Numen Coil Embolization System; NumenFR Detachment System
MicroPort NeuroTech (Shanghai) Co., Ltd.
IVX Fluid Transfer Set
Omnicell, Inc.
Red Light Hair Growth Cap (LP-RJVGRW-BLK)
Shenzhen Idea Light Limited
Stone Clear (SC-LP9-01)
Sonomotion, Inc.
A-LYTE® Integrated Multisensor (IMT Na K Cl)
Siemens Healthcare Diagnostics, Inc.
Lightin System, Lightin, Lightin Generator
Solmedix Co., Ltd.
Arthrex Spine Compression FT Screw
Arthrex, Inc.
OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, O
B-One Ortho, Corp.
STR8 Clear Aligner
Str8 Oral Care
MedicCO2LON (MedicCO2LON)
Ide Vision, Ltd.
Swoop Portable MR Imaging System
Hyperfine, Inc.
Evolution Spine Navigation Instruments
Evolution Spine
Drill Guide; Drill Bit; Spine & Trauma Navigation
Brainlab AG
G0 Blood Pressure Monitoring System (G0)
Aktiia SA
Paltop Short Implants
Paltop Advanced Dental Solutions, Ltd.
Arm Blood Pressure Monitor (model: BPM-A7VL)
Shenzhen Imdk Medical Technology Co., Ltd.
Control-IQ+ technology
Tandem Diabetes Care, Inc.
Electric wheelchair (KR-8807)
Zhejiang Kairui Medical Device Co., Ltd.
Rapid Obstructive Hydrocephalus, Rapid OH
Ischemaview, Inc.
SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)
Edan Instruments, Inc.
AGNES Ultra
Agnes Medical Co., Ltd.
AutoSeg
Ai Medic, Inc.
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
Kontour(XiAn) Medical Technology Co., Ltd.
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