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
CIARTIC Move (VB10)
Siemens Medical Solutions USA, Inc.
Infrared Heat (Model: E0221)
Light Tree Ventures Europe B.V.
Masimo Rad-G with Temperature
Masimo Corporation
3 in 1 TENS UNIT (TC1241, TC2241, TS1241)
Changsha Anxiang Medical Technology Co., Ltd.
Access Toxo IgG
Beckman Coulter, Inc.
Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series
Abbott Laboratories
Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip
Boston Scientific Corporation
ETEST Fosfomycin (FO) (0.032-512 µg/mL)
Biomerieux S.A.
Needle Free Connector
Medcaptain Life Science Co., Ltd.
O-arm O2 Imaging System
Medtronic Navigation, Inc.
Teleflex Rusch SoftSimplastic Foley Catheters
Teleflexmedical, Inc.
Alveoair Digital Spirometer
Roundworks Technologies Private Limited
CuffTrek
Shanghai Longmann Tech Co., Ltd.
VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium
Shenzhen Vitavitro Biotech Co., Ltd.
Blood Pressure Cuff (1201D1,12L2D1,1202D1,12L3D1,1203D1,1204D1,1205D1,1206D1,1207D1-1#,1207D1-2#,1207D1-3#,1207D1-4#,120
Shenzhen Plinma Technology Co. , Ltd.
SGM Femoral Nail System
Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.
NPseal
Guard Medical, Inc.
Toothsi, Smilealigners
Makeo Healthcare Technologies Private Limited
AI4CMR v2.0
Ai4medimaging Medical Solutions S.A.
Bonafix TiBase
Zentek Medical, LLC
pRESET Thrombectomy Device
Phenox Limited
CORAIL Cemented Femoral Stem
Depuy Ireland UC
TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)
Ningbo Tianyi Medical Appliance Co., Ltd.
BodyGuardian Remote Monitoring System (BGRMS v3.0)
Boston Scientific Cardiac Diagnostic Technologies, Inc.
Cochlear Osia System
Cochlear Americas
Self-Forming Magnet (Flexagon Plus OTOLoc)
GI Windows, Inc.
STA R Max 3, STA Compact Max 3
Diagnostica Stago S.A.S
BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter and BD Insyte Autoguard BC P
Becton Dickinson Infusion Therapy Systems, Inc.
AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen Mask
Vyaire Medical, Inc.
Swoop Portable MR Imaging System
Hyperfine, Inc.
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