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

PKP 2023-11-28

VersaPump Infusion System

Applicant Emed Technologies Corporation

K-Number K230883

View Details →

QNW 2023-11-28

Monarch Bronchoscope

Applicant Auris Health, Inc., A Johnson and Johnson Family Company

K-Number K231473

View Details →

DXN 2023-11-28

Digital Blood Pressure Monitor

Applicant Guangdong Genial Technology Co., Ltd.

K-Number K231250

View Details →

MQC 2023-11-28

Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece

Applicant Frey Oral Technologies, LLC

K-Number K222845

View Details →

QIH 2023-11-28

syngo.via MI Workflows; Scenium; syngo MBF

Applicant Siemens Medical Solutions USA, Inc.

K-Number K232000

View Details →

DXN 2023-11-28

Blood Pressure Monitor

Applicant Guangdong Transtek Medical Electronics Co., Ltd.

K-Number K232713

View Details →

JAK 2023-11-28

BriefCase-Quantification

Applicant Aidoc Medical , Ltd.

K-Number K231631

View Details →

QWB 2023-11-28

Cue COVID-19 Molecular Test

Applicant Cue Health, Inc.

K-Number K232643

View Details →

GEI 2023-11-28

Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024)

Applicant Relign Corporation

K-Number K233493

View Details →

LRK 2023-11-28

C.A.R.E. Appliance (DNA, mRNA, mmRNA)

Applicant Vivos Therapeutics, Inc.

K-Number K230947

View Details →

HSN 2023-11-28

Kinos Axiom Total Ankle System

Applicant Restor3D

K-Number K232595

View Details →

GEX 2023-11-28

Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)

Applicant Wuhan Lotuxs Technology Co., Ltd.

K-Number K232117

View Details →

Page 734 of 2738

↑