Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

FXY 2023-10-17

ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)

Applicant Thi Total Healthcare Innovation GmbH

K-Number K222214

View Details →

DZE 2023-10-16

Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL

Applicant Anthogyr

K-Number K230104

View Details →

ODC 2023-10-16

ANDORATE® Valve Kit

Applicant Ga Health Company Limited

K-Number K232118

View Details →

HGX 2023-10-16

Willow Generation 3 Breast Pump

Applicant Willow Innovations, Inc.

K-Number K230570

View Details →

LLZ 2023-10-16

Ikshana

Applicant Immersivetouch

K-Number K230249

View Details →

GCJ 2023-10-16

Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R)

Applicant Hunan Endoso Life Technology Co., Ltd.

K-Number K231725

View Details →

EGJ 2023-10-16

Iontophoresis Electrodes

Applicant Top-Rank Health Care Co., Ltd.

K-Number K232020

View Details →

FLL 2023-10-14

Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)

Applicant Shenzhen AOJ Medical Technology Co., Ltd.

K-Number K232128

View Details →

LLZ 2023-10-13

Veuron-Brain-pAb3

Applicant Heuron Co., Ltd.

K-Number K231642

View Details →

ODP 2023-10-13

Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system)

Applicant Gbs Commonwealth Co., Ltd.

K-Number K232822

View Details →

FRO 2023-10-13

APIS (R), VERIS (TM)

Applicant Sweetbio, Inc.

K-Number K222143

View Details →

NPM 2023-10-13

S1

Applicant Medpark Co., Ltd.

K-Number K231672

View Details →

Page 767 of 2738

↑