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

PSZ 2018-09-18

BioSign Flu A+B

Applicant Princeton BioMeditech Corp.

K-Number K182157

View Details →

CEC 2018-09-18

Elecsys FT4 III

Applicant Roche Diagnostics

K-Number K181233

View Details →

DYB 2018-09-18

The CVC WAND Safety Introducer with Valved Peelable Sheath

Applicant Access Scientific, LLC

K-Number K182243

View Details →

GAM 2018-09-18

Caprolon

Applicant Resorba Medical GmbH

K-Number K181320

View Details →

NKB 2018-09-18

Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System

Applicant OrthoPediatrics Corp.

K-Number K181390

View Details →

GDW 2018-09-18

Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed

Applicant Ethicon Endo-Surgery, LLC

K-Number K181653

View Details →

DPS 2018-09-18

MAC VU360 Resting ECG Analysis System

Applicant Ge Medical Systems Information Technologies, Inc.

K-Number K173830

View Details →

GDW 2018-09-18

Endoscopic Linear Cutting Staplers and Loading Units for Single Use

Applicant Ezisurg (Suzhou) Medical Co., Ltd.

K-Number K181620

View Details →

MAX 2018-09-18

Sypher Spacer System

Applicant Biogennix, LLC

K-Number K181337

View Details →

MQV 2018-09-17

Ceracell Ortho Foam

Applicant Curasan AG

K-Number K181721

View Details →

GEX 2018-09-17

Venacure 1470 Pro

Applicant Quanta System Spa

K-Number K181632

View Details →

NAJ 2018-09-17

CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres

Applicant Suzhou Hengrui Callisyn Biomedical Co., Ltd.

K-Number K173871

View Details →

Page 2052 of 2738

↑