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

OLZ 2017-03-31

EnsoSleep

Applicant Ensodata, Inc.

K-Number K162627

View Details →

NKB 2017-03-31

GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System

Applicant Gpc Medical Limited

K-Number K163096

View Details →

MUU 2017-03-31

Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml, Autoclavable Suction Jar without Luer Lock extension - 1,500 and 2,500 ml, Sterile 1,500 and 2,500 Lids with Conical patient connection 6-10 and overflow protection

Applicant Millennium Medical Technologies, Inc.

K-Number K170449

View Details →

LZC 2017-03-31

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM

Applicant Brightway Holdings Sdn. Bhd.

K-Number K162186

View Details →

DSP 2017-03-31

AC3 Series IABP System

Applicant Arrow International, Inc.

K-Number K162820

View Details →

MBI 2017-03-31

ICONIX TT All Suture Anchor

Applicant Stryker

K-Number K170098

View Details →

MLR 2017-03-31

AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System

Applicant STERIS Corporation

K-Number K162413

View Details →

GWF 2017-03-31

MEP Monitor

Applicant Tonica Elektronik A/S

K-Number K162873

View Details →

JJY 2017-03-31

Multichem IA Plus

Applicant Techno-Path Manufacturing

K-Number K162530

View Details →

LZA 2017-03-31

THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE

Applicant Top Quality Glove Sdn. Bhd

K-Number K162626

View Details →

OQY 2017-03-31

Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component

Applicant Cook Incorporated

K-Number K170622

View Details →

MXD 2017-03-31

BioMonitor 2-AF, BioMonitor 2-S

Applicant Biotronik, Inc.

K-Number K170628

View Details →

Page 2377 of 2685

↑