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

DQY 2019-05-23

Upstream GoBack Crossing Catheter

Applicant Upstream Peripheral Technologies, Ltd.

K-Number K182937

View Details →

QEP 2019-05-23

Aptima Combo 2 Assay (Panther System)

Applicant Hologic, Inc.

K-Number K190515

View Details →

QFO 2019-05-23

ZIKV Detect 2.0 IgM Capture ELISA

Applicant InBios International, Inc.

K-Number DEN180069

View Details →

PQA 2019-05-23

Aptima BV Assay

Applicant Hologic, Inc.

K-Number K190452

View Details →

NKB 2019-05-23

Mariner Outrigger Revision System

Applicant SeaSpine Orthopedics Corporation

K-Number K183639

View Details →

QGN 2019-05-23

Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit

Applicant Cd Diagnostics, Inc.

K-Number DEN180032

View Details →

OMP 2019-05-23

Longterm NPWT Foam Dressing Kit

Applicant Zhejiang Longterm Medical Technology Co., Ltd.

K-Number K182458

View Details →

QEP 2019-05-23

Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit

Applicant Cepheid

K-Number K190441

View Details →

CCK 2019-05-23

MaxCap Ped and MaxCap Neo

Applicant Maxtec, LLC

K-Number K182362

View Details →

EIH 2019-05-23

KATANA Zirconia Block

Applicant Kuraray Noritake Dental, Inc.

K-Number K190436

View Details →

OCX 2019-05-23

ERBEFLO 2 Disposable Tubing System

Applicant Erbe USA, Inc.

K-Number K190469

View Details →

MQP 2019-05-23

SYNMESH System

Applicant Depuy Synthes Spine

K-Number K183054

View Details →

Page 1826 of 2685

↑