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

Ambu® Virobac II® Exhalation Filter

Ambu A/S

Signature™ ONE System

Orthosoft Inc. (D/B/A) Zimmer Cas)

restor3d Reverse Total Shoulder Arthroplasty System

Restor3D

Customize

3D-Side S.A.

TurbAlign

Spirair, Inc.

OBSIDIO Conformable Embolic

Boston Scientific Corporation

VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor

Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.

Intelligence LaserComb

Yibin Yingtong Intelligent Technology Co., Ltd.

Dukal SMS Sterilization Wrap

Dukal, LLC

da Vinci SP Surgical System (SP1098)

Intuitive Surgical, Inc.

Spur Peripheral Retrievable Stent System

Reflow Medical, Inc.

Blood Pressure Monitor

Guangdong Transtek Medical Electronics Co., Ltd.

Soniquence Reusable 3 Button Fingerswitch Wand

Soniquence, LLC

C-Stem AMT LE Prosthesis

Depuy Ireland UC

CoolTone

Zimmer Medizinsysteme GmbH

REDEMPTION Beaming System

Vilex, LLC

SCAR 3

El.En Electroinc Engineering Spa

LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)

Shenzhen Kaiyan Medical Equipment Co., Ltd.

F&P Optiflow Flow Diverter

Fisher & Paykel Healthcare, Ltd.

Momcozy Wearable Breast Pump (BP311)

Shenzhen Root Innovation Technology Co., Ltd.

Syngo.CT Dual Energy

Siemens Medical Solutions USA, Inc.

Hope&Her Vaginal Dilators

Lujena, Inc.

ShiNeo Silicone Implant

Shineo Technology Co., Ltd.

uNion® MAX Cervical Plate System

Ulrich Medical USA, Inc.

Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System

Taiwan Aulisa Medical Devices Technologies, Inc.

17HQ701G-B

Lg Electronics.Inc

Solo+ Tympanostomy Tube Device (TTD)

Aventamed Dac

AAMI3 Isolation Gown

Hubei Xinxin Non-Woven Co., Ltd.

Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33

Yibin Junxin Electronics Technology Co., Ltd.

Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control

Stryker Endoscopy

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