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

Cardiologs Holter Platform

Philips France Commercial

TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)

Shenzhen Jiantuo Electronics Co., Ltd.

Alinity i Total ß-hCG Reagent Kit, GLP systems Track

Abbott Laboratories

Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with

Better Care Plastic Technology Co., Ltd.

EXPLORER AIR® II

Surgvision GmbH

Nutrifit

Vygon USA

AcQMap High Resolution Imaging and Mapping System

Acutus Medical, Inc.

KLS Martin Neuro Rongeurs

KLS-Martin L.P.

Accu-Chek Guide Solo diabetes manager blood glucose monitoring system

Roche Diabetes Care GmbH

CEFALY Connected - OTC, CEFALY Connected - Rx

Cefaly Technology

KardiaMobile 6L

AliveCor, Inc.

da Vinci E-200 Electrosurgical Generator

Intuitive Surgical

Unity Knee PS-C Tibial Insert

Corin U.S.A. Limited

Medical Diode Laser (S1Pro)

Wuhan Pioon Technology Co., Ltd.

Purgo

Aeroclean Technologies, LLC

MeMed BV

MeMed Diagnostics, Ltd.

ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnosti

Siemens Medical Solutions USA, Inc.

Philips MR Patient Care Portal

Invivo Corporation

N2

Megagen Implant Co., Ltd.

Amputee Garment for use with Lympha Press Optimal Plus

Mego Afek AC , Ltd.

Monotime and Optime R

Peters Surgical

SkinStylus SteriLock® MicroSystem, Model Number MP1209SL

Esthetic Medical, Inc.

EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)

Ever Fortune.Ai, Co., Ltd.

ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD

Biomérieux

Aspira Pleural Drainage System

Merit Medical Systems, Inc.

Amferia Wound Dressing

Amferia AB

Sentinel Camera

Ai Optics

Constellation (CON-001)

Q Bio, Inc.

Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet)

Beijing Adss Development Co., Ltd.

Geister K-Rex rongeurs

Geister Medizin Technik GmbH

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