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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