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

LCX 2019-11-22

INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream

Applicant Innovita (Tangshan) Biological Technology Co., Ltd.

K-Number K192843

View Details →

PSQ 2019-11-22

MatriStem UBM Pericardial Patch

Applicant Acell, Inc.

K-Number K191734

View Details →

FMI 2019-11-21

SAM IO Intraosseous Access System

Applicant Sam® Medical Products, Inc.

K-Number K191488

View Details →

DQX 2019-11-21

Asahi PTCA Guide Wire Asahi SION Series

Applicant Asahi Intecc Co., Ltd.

K-Number K191464

View Details →

NJD 2019-11-21

Engage Partial Knee System

Applicant Engage Uni, LLC

K-Number K190439

View Details →

LFD 2019-11-21

CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray

Applicant Oralabs, Inc.

K-Number K181839

View Details →

GEI 2019-11-21

Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories

Applicant Us Medical Innovations, LLC

K-Number K192124

View Details →

DQY 2019-11-21

Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool

Applicant Biotronik, Inc.

K-Number K192996

View Details →

JAK 2019-11-21

SOMATOM Go Platform SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO

Applicant Siemens Medical Solutions USA, Inc.

K-Number K192061

View Details →

JXG 2019-11-21

M. Blue Adjustable Shunt System

Applicant Aesculap, Inc.

K-Number K192266

View Details →

KRD 2019-11-21

Torpedo Gelatin Foam

Applicant Biosphere Medical, S.A.

K-Number K192480

View Details →

MKU 2019-11-21

LZI Cotinine II Enzyme Immunoassay

Applicant Lin-Zhi International, Inc.

K-Number K192299

View Details →

Page 1703 of 2685

↑