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

Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Conn

Cefaly Technology

FUBUKI XF-R Neurovascular Long Sheath

Asahi Intecc Co., Ltd.

PeekMed web

Peek Health, S.A.

C510G/JUSHA-C510G/C510/JUSHA- C510 LCD Monitor

Nanjing Jusha Display Technology Co., Ltd.

Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT

Healgen Scientific,, LLC

Biomet Kirschner Wires (K-Wires)

Biomet, Inc.

BriefCase-Triage

Aidoc Medical , Ltd.

Rezum System

Boston Scientific Corporation

ODI-Tech

Odi Medical AS

Newclip Patient-matched instrumentation non sterile PSI

Newclip Technics

CER-S

Cardiocalm Srl

Arthrex Beaming System

Arthrex, Inc.

Microcurrent device (Model: HBR2-1)

Shenzhen DJ Medical Equipment Co., Ltd.

Tulsa Pro System (Pad-105)

Profound Medical, Inc.

FP3D

Keystone Industries

ApolloHipX (THR.SS.0001)

Corin U.S.A. Limited

ANNE One

Sibel Health, Inc.

TriMed Compression Screws

TriMed, Inc.

ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0)

Medphoton GmbH

Statera-C™ Spinal System

K&J Consulting Corp.

Safety Lancet (XXXV)

Tianjin Huahong Technology Co., Ltd.

Multi-Parameter Patient Monitor

Shenzhen Comen Medical Instruments Co.,Ltd

FONA XDC

Fona S.R.L

Irrigation Tubing Bipolar Cord Set

New Deantronics Taiwan , Ltd.

aboNT SYRINGE

Nipro Medical Corporation

LOGIQ Focus

GE Medical Systems Ultrasound and Primary Care Diagnostics

FaceHeart Vitals Software Development Kit (FH vitals SDK)

Faceheart Corp.

E Blator

New Deantronics Taiwan , Ltd.

Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile

Berpu Medical Technology Co., Ltd.

XLO Brand of Locking Distal Humerus Plating System

Ortho Life Systems Private Limited

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