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

LZC 2019-07-04

Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance Claim

Applicant Central Medicare Sdn Bhd

K-Number K183149

View Details →

FYA 2019-07-04

Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced)

Applicant Medline Industries, Inc.

K-Number K190950

View Details →

MBI 2019-07-03

Infinity Fixation System

Applicant Conmed Corporation

K-Number K191204

View Details →

IZL 2019-07-03

CMDR 2CW (Multiple models)

Applicant Minxray, Inc.

K-Number K191451

View Details →

EBF 2019-07-03

Novidia Flowable Composite

Applicant Nobio , Ltd.

K-Number K182580

View Details →

NQW 2019-07-03

NuVasive® Camber Laminoplasty System

Applicant Nu Vasive, Incorporated

K-Number K191169

View Details →

MAX 2019-07-03

ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K190959

View Details →

MBI 2019-07-03

OsteoFab Suture Anchors

Applicant Oxford Performance Materials, Inc.

K-Number K190915

View Details →

DXN 2019-07-03

Arm-type Electronic Blood Pressure Monitor

Applicant Shenzhen Bsx Technology Electronics Co., Ltd.

K-Number K183058

View Details →

EBF 2019-07-03

XP Composite

Applicant S&C Polymer Silicon- Und Composite Spezialitaeten GmbH

K-Number K182780

View Details →

PFO 2019-07-03

Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments

Applicant Cochlear Americas

K-Number K190589

View Details →

POK 2019-07-03

Koios DS for Breast

Applicant Koios Medical, Inc.

K-Number K190442

View Details →

Page 1799 of 2685

↑