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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

Maxtec MaxBlend2+p

Maxtec, LLC

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B)

Microlife Corporation

NuVasive AttraX Scaffold

Nuvasive, Inc.

Field Shield Wound Dressing

Kericure, Inc.

Medispine - Spinal Needle, Glospine - Spinal Needle

Global Medikit Limited

Neocis Guidance System (NGS) with Intraoral Fiducial Array

Neocis, Inc.

EsoCool Thermal Regulation Catheter

Nuvaira, Inc.

PMW01 Procedure Mask Level 1

Defender Safety, Inc.

Rapid ICH

Ischemaview, Inc.

Alinity i Rubella IgG

Abbott Laboratories

BrightHeart View Classifier

Brightheart

ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of tota

Careplus (M) Sdn Bhd

Electric Wheelchair (AL-208S-063)

Zhongshan A&J Medical Equipment Co., Ltd.

Vivid T8, Vivid T9

GE Medical Systems Ultrasound and Primary Care Diagnostics

CROSSLEAD 0.014inch

Asahi Intecc Co., Ltd.

EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3)

Olympus Medical Systems Corporation

Infusomat® Space Volumetric Infusion Pump Administration Sets

B.Braun Medical, Inc.

Clearblue® Early Digital Pregnancy Test

Spd Swiss Precision Diagnostics GmbH

LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)

Shenzhen Eyco Technology Co., Ltd.

APRO 55 Intermediate Catheter

Alembic, LLC

AlignRT Plus

Vision Rt, Ltd.

Endorail

Endostart S.R.L.

ADI Medical Surgical Face Mask

Asia Dynamics Inc., D/B/A Adi Medical

Methinks CTA Stroke

Methinks Software, S.L

First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First S

W.H.P.M., Inc.

Electric Breast Pump (F5055)

Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.

Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)

Shenzhen Med-Link Electronics Tech Co., Ltd.

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

Advin Biotech, Inc.

RODEO Telescopic Nail

Orthofix Srl

CT Lung Ventilation Analysis Software (CT:V)

4Dmedical Limited

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