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
Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Bl
Shenzhen AOJ Medical Technology Co., Ltd.
Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Re
Ge Medical Systems, LLC
KARL STORZ Trocars with Valve Seals
Karl Storz SE & CO. KG
Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36)
Anhui Jbh Medical Apparatus Co., Ltd.
ReFlow System Mini
Anuncia Medical, Inc.
Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 36
Cardiovascualr Systems, Inc.
TDM Large Bone Plate and Screw System
Tdm Co., Ltd.
SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)
Thera B Medical Products
VivaChek Link Plus Blood Glucose Monitoring System
Vivachek Biotech (Hangzhou) Co., Ltd.
Universal Seal (5-12 mm)
Intuitive Surgical, Inc.
AccuCTP Pro
ArteryFlow Technology Co., Ltd.
Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel
Qingdao Hightop Biotech Co., Ltd.
Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System
Genadyne Biotechnologies, Inc.
cmAngio® (V1.6)
Curemetrix, Inc.
Chemotherapy Gloves
3A Glove Sdn. Bhd.
IceCap product line
Bioserenity Medical Devices Group
OrthoFit
Spident Co., Ltd.
MSS - Monobloc stem
Medacta International S.A.
OpenRad Cloud
Openrad Services Uk, Ltd.
Advanced Algorithms for Treatment Management Applications (AATMA)
Elekta Solutions AB
CollOvine Wound Powder
Ovigenex, LLC
Vena MicroAngioscope System
Vena Medical Holdings Corp
Fine TTO
Bodycad Laboratories, Inc.
da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System
Intuitive Surgical, Inc.
Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Inte
Qura S.R.L
Invisalign Palatal Expander System
Align Technology, Inc.
Kenota 1 Total IgE; Kenota 1 (instrument)
Kenota, Inc.
ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
Genmark Diagnostics, Incorporated
4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)
Shenzhen Sophway Technology Co., Ltd.
Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K
Shenzhen Fansizhe Science and Technology Co., Ltd.
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