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
Alinity c Benzodiazepines Reagent Kit
Microgenics Corporation
ArtiSential Trocar
Livsmed, Inc.
Avantik VTM
Hanchang Medic Co., Ltd. (Han Chang Medic)
ChoiceSpine Navigation System
Choice Spine, LLC
Cemented Tibia Baseplate no Taper with JRNY Lock
Smith & Nephew, Inc.
Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microte
Microtek Medical, LLC
uMI Panorama
Shanghai United Imaging Healthcare Co., Ltd.
ACUSON P500 Ultrasound System
Siemens Medical Solutions USA, Inc.
Molekule Air Pro
Molekule, Inc.
BreathID Hp Lab System, BreathID Smart System
Meridian Bioscience Israel , Ltd.
Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Byte Aligner System
Dentsply Sirona, Inc.
HardyDisk AST Gepotidacin 10µg (GEP10)
Hardy Diagnostics
Wearable Breast Pump (Model S1DW)
Shenzhen TPH Technology Co., Ltd.
FloNavi Open Field Fluorescence Imaging System
Guangdong Optomedic Technologies, Inc.
Double Internal Joint Stabilizer- Elbow
Skeletal Dynamics, Inc.
OXY-1 System
Abiomed, Inc.
HEATING TENS/EMS, FT-810R
Hivox Biotek, Inc.
COVID-19 Detect Rapid Self -Test
InBios International, Inc.
BONHAWA Respiratory Humidifier
Telesair, Inc.
CODA Anterior Cervical Plate System
Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech
ECHELON LINEAR 60 mm Cutter (GLC60);ECHELON LINEAR 80mm Cutter (GLC80);ECHELON LINEAR 100 mm Cutter (GLC100);ECHELON
Ethicon Endo-Surgery
Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356,
Alicn Medical Shenzhen, Inc.
Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CR
Sterilmed, Inc.
MilkMate Breast Pump (A0006); MilkMate Kit (sterile, single-use only), 21 mm breast shield (A0005-21); MilkMate Kit (ste
Milkmate Products, Inc.
MAGNETOM Amira; MAGNETOM Sempra
Siemens Medical Solutions USA, Inc.
Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
Linshom Medical, Inc.
Blue Nitrile Examination Gloves Powder Free
Amazing Rubber Products Pvt, Ltd.
NuVasive Pulse System
Globus Medical, Inc.
Compass Steerable Needle
Serpex Medical, Inc.
Track 510(k) device clearances
Get notified when new devices are cleared in your category.
Set Up Free Alert