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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.

stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® 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 16”D, YJ-011S 16”DF, YJ-011S 18”D, YJ-011S 18”DF, YJ-011S 20”D, YJ-011S 20”DF)

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

EP•XT™ 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.

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