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

DXN 2025-07-14

Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24)

Applicant Jiangxi Aicare Medical Technology Co., Ltd.

K-Number K250185

View Details →

N/A 2025-07-13

Welch Allyn Connex® 360 (Multiple)

Applicant Welch Allyn, Inc.

K-Number K243598

View Details →

POS 2025-07-12

NightWatch+ US

Applicant Livassured BV

K-Number K243199

View Details →

OHT 2025-07-11

Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK)

Applicant Shenzhen Ulike Smart Electronics Co., Ltd.

K-Number K250942

View Details →

NPM 2025-07-11

Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®

Applicant Geistlich Pharma AG

K-Number K251786

View Details →

HBW 2025-07-11

Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System

Applicant Inion OY

K-Number K251472

View Details →

LNH 2025-07-11

Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia Elition S; Ingenia Elition X; Ingenia Ambition S; Ingenia Ambition X; and MR 5300 MR Systems

Applicant Philips Medical Systems Nederland B.V.

K-Number K251808

View Details →

OHS 2025-07-11

KALA Therapy Wand (Model: KALA-03)

Applicant Shenzhen Kaiyan Medical Equipment Co., Ltd.

K-Number K250761

View Details →

KWQ 2025-07-11

Resolve Anterior Cervical Plate System

Applicant Pioneer Surgical Technology, Inc.

K-Number K251436

View Details →

GCJ 2025-07-11

Disposable Trocars

Applicant Sinolinks Medical Innovation, Inc.

K-Number K250820

View Details →

BSZ 2025-07-11

Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration)

Applicant Codonics.Incorporated

K-Number K251352

View Details →

OZE 2025-07-11

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)

Applicant Centers for Disease Control and Prevention

K-Number K243274

View Details →

Page 226 of 2685

↑