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

InferRead Lung CT.AI

Infervision Medical Technology Co., Ltd.

Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)

Neuroelectrics Barcelona S.L.U.

ENFit enteral syringes (NUTRIFIT)

Pentaferte Italia S.R.L.

Denti.AI Detect

Denti.Ai Technology, Inc.

Apollo TMS Therapy System

Mag & More GmbH

InThrill Thrombectomy System

Inari Medical, Inc.

Eko Foundation Analysis Software with Transformers (EFAST)

Eko Health, Inc.

ArtiSential Laparoscopic Instruments-Electrodes

Livsmed, Inc.

Anthogyr Surgical Cassettes

Anthogyr

Catalyst F1x Shoulder System

Catalyst Orthoscience, Inc.

SofWave System

Sofwave Medical, Ltd.

TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge

Haemonetics

EvoEndo Single-Use Endoscopy System

EvoEndo, Inc.

Stabilis SA Cervical Stand-Alone System (Various PNs)

Acuity Surgical Devices, LLC

Aquilion Precision (TSX-304A/4) V10.10 with AiCE

Canon Medical Systems Corporation

Surgical Isolation Cover Gown

Wuhan Dymex Healthcare Co., Ltd.

ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System

Siemens Medical Solutions USA, Inc.

Straumann® PURE Ceramic Implants

Institut Straumann AG

Annalise Enterprise CXR Triage Trauma

Annalise-Ai Pty , Ltd.

RI.KNEE Adjustable Tibia Cut Guide

Enztec Limited

Altus Spine Pedicle Screw System

Altus Partners, LLC

A8 INTEGR8™ Porous Pedicle Screws

Allumin8, Inc.

EyeBOX (Model EBX-4)

Oculogica, Inc.

Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant

Wrp Asia Pacific Sdn. Bhd.

SPINEART Navigation Instrument System

Spineart SA

EdgeFlow UW20

Edgecare, Inc.

ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors

Depuy Ireland UC

JOULE 1064nm System and Accessories

Sciton, Inc

SiJoin®T3

Vgi Medical, Inc.

VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup

Advin Biotech, Inc.

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