Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

MCW 2023-12-15

Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000)

Applicant Eximo Medical, Ltd.

K-Number K233668

View Details →

GEX 2023-12-15

xeo+ Family

Applicant Cutera, Inc.

K-Number K233237

View Details →

MYN 2023-12-15

Videa Dental Assist

Applicant Videahealth, Inc.

K-Number K232384

View Details →

QZA 2023-12-15

Body Temperature Software (BTS)

Applicant Fitbit, LLC

K-Number DEN230050

View Details →

HRS 2023-12-15

Internal Locking Plate and Screw Fixation System

Applicant Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.

K-Number K232394

View Details →

MQV 2023-12-15

MagnetOs Easypack Putty

Applicant Kuros Biosciences B.V

K-Number K233607

View Details →

PRE 2023-12-15

SeptiCyte RAPID

Applicant Immunexpress, Inc.

K-Number K232095

View Details →

OWQ 2023-12-15

Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter

Applicant Surgical Instrument Services and Savings, Inc.

K-Number K232130

View Details →

DPS 2023-12-15

Cardio Q50, Cardio Q70

Applicant Bionet Co., Ltd.

K-Number K231160

View Details →

NUH 2023-12-15

Ova+ (K-OVAP-USA)

Applicant Tenscare, Ltd.

K-Number K230926

View Details →

OWB 2023-12-15

Ziehm Vision FD

Applicant Ziehm Imaging GmbH

K-Number K231700

View Details →

LZA 2023-12-15

Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue)

Applicant Zibo Kaiyue Mould Technology Co., Ltd.

K-Number K233182

View Details →

Page 644 of 2685

↑