Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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 2023-05-17

Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour)

Applicant Hartalega NGC Sdn. Bhd.

K-Number K223437

View Details →

KPS 2023-05-17

Symbia Pro.specta VA20A Family

Applicant Siemens Medical Solutions USA, Inc.

K-Number K231102

View Details →

MBI 2023-05-17

JuggerKnot Soft Anchor

Applicant Riverpoint Medical, LLC

K-Number K231128

View Details →

BZD 2023-05-17

F&P Solo Mask Range

Applicant Fisher & Paykel Healthcare, Ltd.

K-Number K223696

View Details →

MUJ 2023-05-17

Radiation Planning Assistant (RPA)

Applicant University of Texas, MD Anderson Cancer Center

K-Number K222728

View Details →

PSN 2023-05-17

DeepX DermoSight Dermatoscope

Applicant Deepx Health, LLC

K-Number K230448

View Details →

MXC 2023-05-17

Assert-IQ™ Insertable Cardiac Monitor

Applicant ABBOTT MEDICAL

K-Number K230286

View Details →

CBK 2023-05-16

Evita V800, Evita V600

Applicant Draegerwerk AG & CO Kgaa

K-Number K222024

View Details →

ITH 2023-05-16

c1Trac

Applicant Zimmer Medizinsysteme GmbH

K-Number K222912

View Details →

OKP 2023-05-16

SAVI Dual (TM) Migraine Therapy

Applicant Eneura, Inc.

K-Number K230358

View Details →

HIF 2023-05-16

Insufflator

Applicant Scivita Medical Technology Co., Ltd.

K-Number K222812

View Details →

QOF 2023-05-16

Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay

Applicant Hologic, Inc.

K-Number K222736

View Details →

Page 886 of 2738

↑