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

HRS 2021-10-01

Anthem Fracture System

Applicant Globus Medical, Inc.

K-Number K212433

View Details →

DPS 2021-10-01

electrocardiograph: SE-1202

Applicant Edan Instruments, Inc.

K-Number K210140

View Details →

PJN 2021-10-01

OSSDSIGN Cranial PSI

Applicant Ossdsign AB

K-Number K212414

View Details →

KRD 2021-10-01

HRSpheres Narrow-Size Embolic Microspheres

Applicant Suzhou Hengrui Hongyuan Medical Co., Ltd.

K-Number K210562

View Details →

DXN 2021-10-01

Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09

Applicant Edan Instruments, Inc.

K-Number K210139

View Details →

PNN 2021-10-01

BRIUS Planner Software

Applicant Brius Technologies, Inc.

K-Number K212828

View Details →

IYE 2021-10-01

Elekta Unity

Applicant Elekta Solutions AB

K-Number K212114

View Details →

IPF 2021-10-01

STELLA BIO

Applicant Egzotech Sp. Z O. O.

K-Number K210002

View Details →

OWB 2021-10-01

Zenition 70

Applicant Philips Medical Systems Nederland B.V.

K-Number K212813

View Details →

FET 2021-10-01

D Camera Controller

Applicant Richard Wolf Medical Instruments Corporation

K-Number K211332

View Details →

LPH 2021-10-01

E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS

Applicant Microport Orthopedics, Inc.

K-Number K200011

View Details →

PCV 2021-10-01

PENTAX Medical Auto Leakage Tester SHA-P6

Applicant Pentax of America, Inc.

K-Number K212201

View Details →

Page 1317 of 2744

↑