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

Gastric Alimetry System

Alimetry , Ltd.

IPL Hair Removal

Shenzhen Qiaochengli Technology Co., Ltd.

syngo.via MI Workflows; Scenium; syngo MBF

Siemens Medical Solutions USA, Inc.

sam 2.0 Long Ultrasound Device

ZetrOZ Systems, LLC

Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp

Wontech Co., Ltd.

Hearing Aid Feature (HAF)

Apple, Inc.

Clear Aligners

Shenzhen Yinuo Dental Technology Co.Ltd

Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Periphera

Infraredx, Inc.

Medline Open-back Level 3 Protective Gown

Medline Industries, LP

Tesera-k ALIF System

Kyocera Medical Technologies, Inc.

FloPatch FP120

Flosonics Medical

Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) - Blue/Black/Purple

Jiangsu Bytech Medical Supplies Co., Ltd.

AIR Recon DL

Ge Medical Systems,Llc (Ge Healthcare)

Avanos* CORTRAK* 2 Enteral Access System (EAS)

Avanos Medical, Inc.

MOR

Morari, Inc.

Suture Button Repair System

Skeletal Dynamics, Inc.

EchoPAC Software Only / EchoPAC Plug-in

GE Medical Systems Ultrasound and Primary Care Diagnostics

Gnesis EMS Plus

Creative Fitness Developments S.L.

Dukal Corporation Level 1 Pediatric Face Mask

Dukal Corporation

Voluson Expert 18; Voluson Expert 20; Voluson Expert 22

GE Medical Systems Ultrasound and Primary Care Diagnostics

EzDent-i/ E2/ Prora View/ Smart M Viewer

Ewoosoft Co., Ltd.

BunkerHill BMD

BunkerHill Health

CUSA® Clarity Ultrasonic Surgical Aspirator System

Integra LifeSciences Corporation

SOTA Cloud Smart Sensor (1.5)

Sota Cloud Corp.

SIGNA Prime Elite

Ge Medical Systems, LLC

CoroFlow Cardiovascular System

Coroventis Research AB

Smile-100 System

Niramai Health Analytix Private Limited

Ponto 5 Mini

Oticon Medical AB

BE Plus PRO, Neurotravel LIGHT

Eb Neuro S.P.A.

Pre-Filled Normal Saline Flush Syringe

Anhui Tianyang Pharmaceutical Co., Ltd.

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