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

Electrically Powered Wheelchair (Model YC-01)

Yurob Rehabilitation Medical Co., Ltd.

Endura™ Ureteral Stent and Stent Set

Cathegenix (Xiamen) Co., Ltd.

Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D)

Gigaalaser Company , Ltd.

EndoTool SubQ 2.1

Monarch Medical Technologies, LLC

LuxCreo Clear Aligner System

LuxCreo, Inc.

ALIGN Radial Head System

Skeletal Dynamics, Inc.

Vy Spine ClariVy Cervical IBF System

Vy Spine, LLC

Cionic Neural Sleeve NS-100

Cionic

Electrically Powered Wheelchair

Kunshan Hi-Fortune Health Products Co., Ltd.

IPL Home Use Hair Removal Device

Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd.

Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherap

Yty Industry (Manjung) Sdn Bhd

Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)

Shenzhen Root Innovation Technology Co., Ltd.

Epildream HP 4000 MED

D.E.A Project S.R.1.

Picocaremajesty

Wontech Co., Ltd.

MagnetOs MIS

Kuros Biosciences B.V

Spineology Navigation Instruments

Spineology, Inc.

Anchor with Fiber Wire and Disposable Inserter

Ortobio S.A.

Saffron Fixation System

Coloplast A/S

Accuray Precision Treatment Planning System

Accuray Incorporated

Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and Fentanyl

Zibo Lanhua Medical Packaging Material Co., Ltd.

DentCare Aligners

Dentcare Dental Lab Pvt , Ltd.

WHILL Model F

Whill, Inc.

XD

Mirada Medical, Ltd.

DOC Band 3D

Cranial Technologies, Inc.

Coresculpt & Magsculpt

K1Med Co., Ltd.

Compremium Compartment Compressibility Monitoring System (CPM#1)

Compremium AG

Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR

Canon Medical Systems Corporation

Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture ancho

Suzhou Endophix Co., Ltd.

Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup

Vivachek Biotech (Hangzhou) Co., Ltd.

Newclip Patient-matched instrumentation non sterile PSI

Newclip Technics

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