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

Dental sensors NanoPix1, NanoPix2

Iray Technology Taicang , Ltd.

uCerv Flux™-C 3D Porous Titanium Cervical Interbody

Ulrich Medical USA, Inc.

OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor

Riverpoint Medical

Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable (HNSAG-5110M); Single Use Non-Stick Jewelle

Hg Innovations, Ltd.

Intra.Ox 2.0 Handheld Tissue Oximeter

Vioptix, Inc.

Aura 10 PET/CT

Xeos Medical

Preat Abutments

Preat Corporation

Polyisoprene Surgical gloves

Suzhou Colour-Way New Material Co., Ltd.

BruxZir Esthetic

Prismatik Dentalcraft, Inc.

coactiv+™ Antimicrobial Wound Gel

Kane Biotech, Inc.

Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter

Medtronic

Surgical Face Mask

Xiantao Deming Healthcare Products Co., Ltd.

Zavation Navigation Instrument System

Zavation Medical Products, LLC

Remex KA6

Remedi Co., Ltd.

Endoskeleton™ Interbody Systems

Medtronic Sofamor Danek USA, Inc.

DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)

Devilbiss Healthcare, LLC

Suture Button Repair System

Skeletal Dynamics, Inc.

ICEfx Cryoablation System (FPRCH8000-02)

Boston Scientific

Paneffort 3-ply Surgical and Procedural Masks

Paneffort, LLC

Real Intelligence Cori

Blue Belt Technologies, Inc.

FreeStyle Comfort (AS200 / FreeStyle Comfort)

Caire, Inc.

MiVu™ Esophageal Endo Cap

Diversatek Healthcare

uCT 780 with uWS-CT-Dual Energy Analysis

Shanghai United Imaging Healthcare Co., Ltd.

Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)

Beijing HuaCheng Taike Technology Co., Ltd.

CONMED Argo Knotless® Anchor

Conmed Corporation

Varion Thoracolumbar Fixation System

Kyocera Medical Technologies Inc. (KMTI)

Locking Screw,CoCrMo

Double Medical Technology, Inc.

AT-Patch (ATP-C130/ATP-C70)

Atsens Co., Ltd.

Arthrex Vortex Threaded Bone Marrow Recovery Needle

Arthrex, Inc.

iQ-solutions

Sydney Neuroimaging Analysis Centre Pty, Ltd.

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