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

LZA 2021-10-29

SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free

Applicant Srirungruang Global Co., Ltd.

K-Number K212308

View Details →

QQY 2021-10-28

APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module

Applicant Clever Culture Systems

K-Number K200839

View Details →

LZA 2021-10-28

Examination gloves -Type C (Nitrile gloves)

Applicant Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.

K-Number K212290

View Details →

FLE 2021-10-28

AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers

Applicant STERIS Corporation

K-Number K212424

View Details →

PML 2021-10-28

BonOs Inject Bone Cement; NEO Pedicle Screw System

Applicant Neo Medical SA

K-Number K212489

View Details →

NDC 2021-10-28

EndoTool SubQ 2.1

Applicant Monarch Medical Technologies, LLC

K-Number K211160

View Details →

GEI 2021-10-28

Disposable Monopolar Laparoscopic Tips and Reusable Handles

Applicant Dannik, LLC

K-Number K211019

View Details →

LZA 2021-10-28

Disposable Nitrile Examination Gloves (Powder free, Blue)

Applicant Leping Shengde Medical Technology Company Limited

K-Number K211581

View Details →

NDN 2021-10-28

TRACKER Plus Kyphoplasty System

Applicant GS Medical Co., Ltd.

K-Number K211797

View Details →

LON 2021-10-28

VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)

Applicant bioMerieux, Inc.

K-Number K210287

View Details →

FTM 2021-10-27

PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology

Applicant Synovis Life Technologies. Inc. (A Subsidiary of Baxter

K-Number K213125

View Details →

LZA 2021-10-27

Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs

Applicant Shanxi Hongjin Plastic Technology Co., Ltd.

K-Number K211604

View Details →

Page 1227 of 2685

↑