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

OCC 2017-12-04

Panther Fusion AdV/hMPV/RV Assay

Applicant Hologic, Inc.

K-Number K172629

View Details →

PSQ 2017-12-04

PhotoFix Decellularized Bovine Pericardium

Applicant Cryolife, Inc.

K-Number K172085

View Details →

MAX 2017-12-04

Velofix™ TLIF Cage

Applicant U&I Corporation

K-Number K172419

View Details →

LRX 2017-12-04

Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc

Applicant Alcon Laboratories, Inc.

K-Number K173538

View Details →

PDJ 2017-12-04

ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K171771

View Details →

MAX 2017-12-04

SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Spacer System -Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Vu e·POD System

Applicant SeaSpine Orthopedics Corporation

K-Number K173260

View Details →

QEW 2017-12-04

ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath

Applicant Inari Medical

K-Number K173470

View Details →

NGX 2017-12-04

PowerDot PD-01M

Applicant Smartmissimo Technologies Pte, Ltd.

K-Number K172876

View Details →

OCW 2017-12-01

CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor

Applicant Sutureease, Inc.

K-Number K172666

View Details →

HSB 2017-12-01

PRECICE System

Applicant Nuvasive Specialized Orthopedics, Inc.

K-Number K173129

View Details →

FRO 2017-12-01

Alevicyn SG Antimicrobial Gel

Applicant Sonoma Pharmaceuticals, Inc.

K-Number K171935

View Details →

ODP 2017-12-01

ACIF

Applicant Coligne AG

K-Number K173148

View Details →

Page 2249 of 2738

↑