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

MCW 2018-04-17

ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System

Applicant Cardiovascular Systems, Inc.

K-Number K180416

View Details →

PKL 2018-04-16

Hemoclip

Applicant Hangzhou AGS MedTech Co., Ltd.

K-Number K172727

View Details →

KWQ 2018-04-16

Mediant Anterior Cervical Plating System

Applicant Intelligent Implant Systems, LLC

K-Number K173935

View Details →

FAD 2018-04-16

Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set

Applicant Cook Incorporated

K-Number K171603

View Details →

OBH 2018-04-16

SOZO

Applicant ImpediMed Limited

K-Number K180126

View Details →

HIH 2018-04-16

GDT-1000 System

Applicant Acuvu, Inc.

K-Number K180096

View Details →

DHB 2018-04-16

ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut

Applicant Phadia AB

K-Number K173726

View Details →

DPS 2018-04-16

CardiMax Electrocardiograph

Applicant Fukuda Denshi USA, Inc.

K-Number K173226

View Details →

FRO 2018-04-13

Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)

Applicant Aquilabs Us, LLC

K-Number K180305

View Details →

GEI 2018-04-13

Voyant Open Fusion Device

Applicant Applied Medical Resources Corporation

K-Number K180699

View Details →

MQB 2018-04-13

SmartGrid

Applicant Carestream Health, Inc.

K-Number K180667

View Details →

IYN 2018-04-13

U60 Diagnostic Ultrasound System

Applicant Edan Instruments, Inc.

K-Number K180408

View Details →

Page 2096 of 2685

↑