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

ONVOY™ Acetabular System

Globus Medical, Inc.

Mobility Scooter (S3)

Shenzhen Zhimahuaerkai Technology Co., Ltd.

Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)

Unimed Medical Supplies, Inc.

Swang-Ganz IQ pulmonary artery catheter

Edwards Lifesiences, LLC

Planmed Clarity 2D, Planmed Clarify S

Planmed OY

SACS PRO

Elastimed , Ltd.

b-ONE MOBIO Total Knee System

B-One Ortho, Corp.

CoAptix S System

University of Utah, Department of Orthopaedics

Disposable, vinyl examination gloves, Yellow

Dezhou Hengchang Medical Technology Co., Ltd.

4CIS Chiron Spinal Fixation System

Solco Biomedical Co., Ltd.

EMERGE™ Anterior Cervical Plate System

Evolution Spine

Zimmer Persona Personalized Knee System

Zimmer, Inc.

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

Centers for Disease Control and Prevention

Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit

Stryker Corporation

BioXmark

Nanovi A/S

QFR (3.0)

Qfr Solutions BV

Arthrex SoftStitch

Arthrex, Inc.

Powder-Free Nitrile Examination Gloves

Global Protection Corp.

Durex Penck III Regular

Rb Health (Us), LLC

Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fe

Central Medicare Sdn Bhd

VERIQA RT EPID 3D

Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla

Human Lubricant

Jiangxi Wulinxiang Biological Technology Co., Ltd.

Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters)

Covidien

HAtetracell™-C Titanium Cervical IBF System

Innovasis, Inc.

HealthCCSng

Zebra Medical Vision, Ltd.

Geistlich Wound Matrix PLUS

Geistlich Pharma AG

Extremity All Suture System

Field Orthopaedics

Hexa-Temp

Spident Co., Ltd.

Geonic Nasal Aspirator, Geonic Nasal Cleaner

Geon Corporation

CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739)

Okapi Medical, LLC Dba Resivant Medical

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