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

Access Cortisol; DxC 500i Clinical Analyzer

Beckman Coulter, Inc.

eZSURE™ Empty Fluid Container

Epic Medical Pte. , Ltd.

MARVEL™ Growing Rods

Globus Medical, Inc.

FlareHawk Interbody Fusion System

Integrity Implants Inc. Dba Accelus

Electrocardiograph

Edan Instruments, Inc.

Surgical Masks

Hubei Xinxin Non-Woven Co., Ltd.

Edison System

HistoSonics, Inc.

EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

Philips Ultrasound, LLC

AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent); AXIOS Stent and Electrocautery-Enhanced De

Boston Scientific Corporation

Francisella tularensis Real-time PCR assay

Centers for Disease Control and Prevention

Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape)

Smith & Nephew, Inc.

Power wheelchair (N6101)

Zhejiang Zhonglei Medical Technology Co. , Ltd.

Mochida Nerve Cuff

Mochida Pharmaceutical Co., Ltd.

Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System

Howmedica Osteonics Corp. dba Stryker Orthopaedics

Respond OC Conserving Regulator (130-0800)

Responsive Respiratory

Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)

Beijing Konted Medical Technology Co.,Ltd

EMPHASYS Acetabular System

Depuy Ireland UC

TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)

Nihon Kohden Corporation

hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS

Cefla S.C.

Socrates 38 Catheter

Scientia Vascular, Inc.

ACIST RXi System (016616); ACIST Navvus II Catheter (016675_

Acist Medical Systems, Inc.

Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001, QN-N002, QN-N003, QN-N004, QN-N005)

Ningxia Qiaoen Medical Technology Co., Ltd.

HOLLYWOOD SPECTRA Laser System

Lutronic Corporation

Eversense AP CGM System

Senseonics, Incorporated

Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)

Zhengzhou PZ Laser Slim Technology Co., Ltd.

Montross Extremity Medical Hemi Implant System

Montross Extremity Medical

Hemoclip

Hangzhou AGS MedTech Co., Ltd.

Vivid T8, Vivid T9

GE Medical Systems Ultrasound and Primary Care Diagnostics

Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314,

Shenzhen Yimi Life Technology Co., Ltd.

Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand (HD-44)

Shenzhen Nuon Medical Equipment Co., Ltd.

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