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

PiXel8-Reveal

Rohrer Aesthetics

F&P Nova Nasal Mask

Fisher & Paykel Healthcare Limited

Catapult Guide Sheath

Contract Medical International, GmbH

VI°Port™ Liver Preservation System

Traferox Technologies, Inc.

LOCATOR® Angled Abutment

Zest Anchors, LLC

leva Pelvic Health System

Renovia, Inc.

Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe

Medline Industries, Inc.

VITROS Immunodiagnostic Products Intact PTH II Reagent Pack

Ortho Clinical Diagnostics

Access Thyroglobulin Antibody II

Beckman Coulter, Inc.

Insight Enhanced™ DRF (EN-1002-01)

Imaging Engineering, LLC

i2Contour

Mrimath, LLC

Luja Coude (20108 Male CH18 - large packaging)

Coloplast Corp.

Keos Anterior Cervical Interbody Fusion Device System

Keos

VPAP Pediatric Face Mask

Hsiner Co., Ltd.

Ziehm Vision RFD 3D

Ziehm Imaging GmbH

TearCare System

Sight Sciences, Inc.

LILY Extension Tube and Needleless Connector

Lily Medical Corporation

MAGNETOM Vida, MAGNETOM Sola

Siemens Medical Solutions USA, Inc.

Vis-U-All Low Temperature Sterilization Pouches

STERIS Corporation

Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24)

Jiangxi Aicare Medical Technology Co., Ltd.

Anchor Bolts as Accessories to Depth Electrodes

Ad-Tech Medical Instrument Corporation

NovoSorb BTM

Polynovo Biomaterials Pty, Ltd.

Peleton Universal Single Use Power System and Attachments

Peleton Surgical

NightGuard Flex

Sprintray, Inc.

G0 Blood Pressure Monitoring System (G0)

Aktiia SA

ROSA ONE Brain application

Medtech S.A.S

ZQuiet Advance

Sleeping Well, LLC

MISHA Knee System

Moximed, Inc.

mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit

MED-EL Elektromedizinische Geräte GmbH

Pocket Ultrasound System

Guangdong Youkey Medical Co., Ltd.

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