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

FRC 2017-12-12

SporView Rapid Read Biological Indicator

Applicant Crosstex/Spsmedical, A Division of Cantel Medical

K-Number K172432

View Details →

JDR 2017-12-11

SNIPER STAPLE SYSTEM, NON-STERILE

Applicant Trilliant Surgical

K-Number K172405

View Details →

KPR 2017-12-11

Optima XR646 HD

Applicant Ge Hualun Medical Systems Co. , Ltd.

K-Number K173612

View Details →

MSS 2017-12-11

Crystalsert Lens Delivery System

Applicant Bausch & Lomb, Inc.

K-Number K173480

View Details →

NKB 2017-12-11

CorticaLINK Spinal Fusion Platform

Applicant Linkspine, Inc.

K-Number K173484

View Details →

FMI 2017-12-11

Safety Blood Collection Device for Single Use

Applicant Gemtier Medical (Shanghai), Inc.

K-Number K170276

View Details →

PRI 2017-12-10

Lumipulse G BRAHMS PCT Immunoreaction Cartridges, Lumipulse G BRAHMS PCT Calibrators set

Applicant Fujirebio Diagnostics,Inc.

K-Number K172713

View Details →

LSR 2017-12-10

Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)

Applicant Euroimmun Us, Inc.

K-Number K172722

View Details →

NUH 2017-12-08

Wireless Pain Relieve Device Model: LT5018C

Applicant Shenzhen Dongdixin Technology Co., Ltd.

K-Number K173462

View Details →

MUU 2017-12-08

LipiVage

Applicant Genesis Biosystems, Inc.

K-Number K172714

View Details →

PBX 2017-12-08

InMode PLUS System

Applicant Inmode MD , Ltd.

K-Number K172302

View Details →

FYA 2017-12-08

RoyalGuard Surgical Gown, i600, Breathable

Applicant Gri Medical & Electrical Technology Co., Ltd.

K-Number K172445

View Details →

Page 2187 of 2685

↑