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

LOGIQ E10s, LOGIQ Fortis

GE Healthcare

OmniTom Elite

Neurologica Corporation

CINtec Histology

Ventana Medical Systems, Inc.

Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201

Zhejiang Lude Technology Development Co., Ltd.

Bolt Intravascular Lithotripsy (IVL) System

Bolt Medical, Inc.

Portable Dental X-ray Device (GT-1)

Guilin Refine Medical Instrument Co., Ltd.

Insulin Syringe

Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.

BioClean Implant Restorative System

Bioclean Dental, LLC

Helios+ UV-C System

Preventamed Technologies, Inc. Dba Surfacide Manufacturing

Latex Examination Powder Free Gloves

Aspen Glove Sdn. Bhd.

StrokeSENS ASPECTS Software Application

Circle Cardiovascular Imaging, Inc.

Syncron-E

Autonomous Healthcare, Inc.

Atalante X

Wandercraft SAS

AI4CMR v1.0

Ai4medimaging Medical Solutions S.A.

Dental Implants and Abutments

Ditron Dental, Ltd.

DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System

Synthes GmbH

BresoDX1

Bresotec, Inc.

Luna Dental Implant System

Shinhung Mst Co., Ltd.

Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Trans

Stryker Sustainability Solutions

Fusion Bioline Vascular Graft

Maquet Cardiovascular, LLC

Arthrex Variable Angle (VA) Proximal Tibia Plating System

Arthrex, Inc.

Syngo Carbon Clinicals (VA41)

Siemens Healthineers AG

Invictus Robotic Navigation Instruments

Alphatec Spine

TrainFES Advance

Trainfes

Hemafuse System

Sisu Global Health

Fitbit Irregular Rhythm Notifications

Fitbit, Inc.

MFG-05

Zimmer Medizinsysteme GmbH

OSSIX Breeze

Datum Dental, Ltd.

EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100

Olympus Medical Systems Corporation

ACUSON Sequoia Diagnostic Ultrasound System

Siemens Medical Solutions USA, Inc.

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