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

Fetal EchoScan

Brightheart

uLab Systems Dental Aligner Kit

Ulab Systems, Inc.

CAS-One IR

Cascination AG

Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB

Joytech Healthcare Co. , Ltd.

Medical diode laser systems (CHARISMA, REGAL)

Reveal Lasers , Ltd.

ECMT-100 WMD

Ecm Therapeutics, Inc.

LYNX COBLATION Laryngeal Wand (72290254)

ArthroCare Corporation

Vulcan Spinal System

K2m, Inc.

ZSFab Lumbar Interbody System

Zsfab, Inc.

Medicon Epiplating System

Cmf Medicon Surgical, Inc.

Triathlon Pro

Sigma Biomedical

Bio Fluff System

Gnali Bocia S.R.L.

Ablation-fit

R.A.W. S.R.L

Lumify Diagnostic Ultrasound System

Philips Ultrasound, LLC

Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fitness 42/3 TLT by Ergoline, Ergoline Vita

Jk-Holding GmbH

CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System

Abbott (Formerly Thoratec Corporation)

Philips IntelliSite Pathology Solution 5.1

Philips Medical Systems Nederland B.V.

Genius AI Detection 2.0

Hologic, Inc.

ERI Handheld Dental X-ray System (Model AG100)

Energy Resources International Co., Ltd. Hsinchu Branch

Sterile Syringes for Single Use

Shanghai Kindly Enterprise Development Group Co., Ltd.

Endo Motor

Shenzhen Perfect Medical Instruments Co., Ltd.

DTX Studio Clinic (4.0)

Nobel Biocare AB

CMN Capillary Function with Oncology Virtual Expert

Cercare Medical A/S

Unscented Menstrual Tampon

Suzhou Borage Medical Technology Co., Ltd.

Medcare Powder-Free Blue Nitrile Patient Examination Gloves

Dongguan Grinvald Technology Co., Ltd.

ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))

1987 Media Limited

RAYDENT SW

Ray Co., Ltd.

Omni Legend

Ge Medical Systems Israel, Functional Imaging

AXS Lift Intracranial Base Catheter

Stryker Neurovascular

HPR45i

F Care Systems USA, LLC

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