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
TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
Haemonetics Corporation
Emerge Monorail PTCA Dilatation Catheter
Boston Scientific
LightStim for Wrinkles (1984); LightStim for Acne (2038)
Led Intellectual Properties, LLC
Dukal SMS Sterilization Wrap
Dukal, LLC
A.B. Dental Devices Dental Implants System
A.B. Dental Device , Ltd.
AirLife DuoTherm Humidification System
Vyaire Medical, Inc.
FirstFit Surgical Kit
Freudenberg Medical, LLC
MitraPatch Mitral Valve Repair System
Chawla Heart Technologies, LLC
uAngio AVIVA CX
Shanghai United Imaging Healthcare Co., Ltd.
SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reli
Globus Medical, Inc.
Disposable Stone Extraction Basket
Zhejiang Soudon Medical Technology Co., Ltd.
Zionic Pro Max (Radiofrequency)
Termosalud S.L.
Introcan Safety 3 Closed IV Catheter
B.Braun Medical, Inc.
Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)
Agada Medical, Ltd.
QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)
Fysicon BV
Procise ADL
Procisedx, Inc.
YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff
Nihon Kohden Corporation
IntelliSep Test
Cytovale, Inc.
Apollo ESG NXT System, Apollo REVISE NXT System
Apollo Endosurgery, Inc.
LTV2 Series Ventilators
Vyaire Medical, Inc.
Molecular Transport Media - MTM
Alb Luz
Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4)
Sichuan Qianii-Beoka Medical Technoiogy Lnc.
Vathin Video Bronchoscope System
Hunan Vathin Medical Instrument Co., Ltd.
Compression Therapy Device (LGT-2202DVT)
Guangzhou Longest Medical Technology Co., Ltd.
Ambu® aScope 5 Broncho 2.7/1.2, Ambu® aScope 5 Broncho 4.2/2.2, Ambu® aBox 2
Ambu A/S
RZ Resectoscope System
Rz Medizintechnik GmbH
BioHorizons CEREC Compatible Ti-Bases
BioHorizons Implant Systems, Inc.
EffortMed Spinal Fixation System
Effortmed, LLC
Access EPO
Beckman Coulter, Inc.
CO2 Laser Therapy System (K106)
Hebei Keylaser Sci-Tech Co.,Ltd
Track 510(k) device clearances
Get notified when new devices are cleared in your category.
Set Up Free Alert