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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

Versalock Rib and Sternum Plates System

GM Dos Reis Industria e Comercio Ltda.

Cove Putty, OsteoCove Putty

SeaSpine Orthopedics Corporation

Power Wheelchair (JJW-6001)

ZheJiang J&J Mobility Co., Ltd.

Fluido® AirGuard System

The Surgical Company International BV (As Tsc Life)

Oxus Sieve Beds

Oxus, Inc.

SonoStik Guide Wire Introducer

Sonostik, LLC

Contour ProtégéAI+

Mim Software, Inc.

Microwave Ablation Device

Nanjing Dewen Medical Technology Co., Ltd.

Boehringer Laboratories Liver Retractor

Boehringer Laboratories, LLC

ORAcollect®•Dx

DNA Genotek, Inc.

Sugita AVM Microclip Applier

Mizuho America, Inc.

PrecivityAD2 Test

C2N Diagnostics, LLC

EchoSolv AS

Echo IQ, Ltd.

IPL Hair Removal Device

Ulike Co., Ltd.

Vigilant Software Suite – Vigilant Master Med

Fresenius Kabi AG

Merge Universal Viewer (MUV)

Merge Healthcare Incorporated

LOGIQ Totus

GE Medical Systems Ultrasound and Primary Care Diagnostics

UltraSight AI Guidance

Ultrasight, Inc.

OptiComp

Pac-Dent, Inc.

Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, A

Huizhou Lvb Maternal and Infant Supplies Co., Ltd.

MAVERICK External Fixation System

Smith & Nephew, Inc.

Laser hair growth helmet

Kam Yuen Plastic Products , Ltd.

OsteoFlo HydroFiber

SurGenTec, LLC

MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)

Guangzhou Decheng Biotechnology Co., Ltd.

LF900

Daesung Maref Co., Ltd.

Green X 21 (PHT-90CHO)

VATECH Co., Ltd.

Medicell Mycosis Laser (MCML24004)

Medicell Healthcare Co.,LTD

Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures

Arthrex, Inc.

canturio® se (Canturio Smart Extension)

Canary Medical USA, LLC

Sprinter Legend Rapid Exchange Balloon Dilatation Catheter

Medtronic, Ireland

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