RecallHawk

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

LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elit

Boston Scientific Corporation

Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)

Nemoto Kyorindo Co., Ltd.

Tiger 2 System

Zavation Medical Products, LLC

Nitrile Examination Gloves

Wuhan Huirui Technology Co., Ltd.

WavelinQ™ Generator

C.R. Bard, Inc.

Disposable Nitrile Examination Gloves

Chifeng Huawei Medical Science&Technology Co., Ltd.

Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement

Depuy Ireland UC

YUWELL Electronic Blood Pressure Monitor

Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20

Shenzhen Smallsignal Technology Co., Ltd.

ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress

Inomed Medizintechnik GmbH

PlanOne 1

Cosylab Jsc, Control System Laboratory

Oligio X

Wontech Co., Ltd.

Synthetic Nitrile Examination Gloves

Shandong Hongxin Chemicals Co., Ltd.

DuraGraft

Marizyme, Inc.

Masimo W1

Masimo Corporation

Patriot-SI Posterior Implant System

Spinal Simplicity, LLC

16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)

Quality Electrodynamics

OdneClean

Odne AG

syngo Application Software

Siemens Medical Solutions USA, Inc.

Neodent Implant System - GM Zygomatic Implant System

JJGC Indústria e Comércio de Materiais Dentários S.A.

G-BLOCK

Graphenano Dental S.L.

C&B 5.0 Hybrid

Arum Dentistry Co., Ltd.

Equinoxe® Shoulder System

Exactech, Inc.

SpineAR SNAP

Surgical Theater, Inc.

Allograft Delivery Device (OFAC-C)

Bioventus, LLC

Visby Medical Sexual Health Test

Visby Medical

BAROguard

Paragonix Technologies

Cios Select (VA21) Flat Panel

Siemens Medical Solutions USA, Inc.

Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile)

Pt. Universal Gloves

Avara Viewer

Avara Software

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