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
Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)
Ge Medical Systems Information Technologies, Inc.
Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)
Zhuhai Pusen Medical Technology Co., Ltd.
Alteon® HA Femoral Stems
Exactech, Inc.
AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G
H.S Hospital Service S.P.A
Aurelia Surgical Mask ASTM Level-3 (2130)
Supermax Healthcare Canada Supermax Medical
Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026)
Dongguanshi Yiyingmei Technology Co., Ltd.
staysafe® catheter extension set with Safe- Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 6 inch; st
Fresenius Medical Care Renal Therapies Group, LLC
Disposable Belts for Polysomnography (CNSAC)
CNSAC Medshop GmbH
TENS and EMS Unit
Changsha Anxiang Medical Technology Co., Ltd.
eFOLDi Navigator Powerchair (STPC-A)
Suntech UK , Ltd.
ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)
H&abyz Co., Ltd.
Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
KIDNEY ASSIST-transport
Xvivo Perfusion AB
Pen Injector
Wuxi Nest Biotechnology Co., Ltd.
BTI Interna Prosthetic Components
B.T.I. Biotechnology Institute, Sl.
Cambridge Partial Knee
Signature Orthopaedics Pty, Ltd.
iTFlow
Cardio Flow Design, Inc.
Lung Guidance
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
Reclining wheelchair (YJ-011S 16D, YJ-011S 16DF, YJ-011S 18D, YJ-011S 18DF, YJ-011S 20D, YJ-011S 20DF)
Zhenjiang Assure Medical Equipment Co., Ltd.
Gemini 2 810+980 Soft Tissue Laser
Azena Medical, LLC
Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)
Shenzhen Changkun Technology Co., Ltd.
Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws
Exactech, Inc.
Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)
Stryker Sustainability Solutions
Facet Manatee Reusable Lancing Base
Facet Technologies, LLC
EPXT Unidirectional Steerable Diagnostic Catheter; Dynamic Tip Unidirectional Steerable Diagnostic Catheter; Dynamic
Boston Scientific Corporation
Wet Flavored Personal Lubricants
Trigg Laboratories, Inc.
Respire Clear
Respire Medical, LLC
MicroPen EVO
Eclipse Medcorp, LLC
Legend X Platform
Pollogen, Ltd.
Track 510(k) device clearances
Get notified when new devices are cleared in your category.
Set Up Free Alert