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

JOP 2024-12-18

Falcon/Xpress (Falcon/Xpress)

Applicant Viasonix , Ltd.

K-Number K242662

View Details →

FAJ 2024-12-18

Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2)

Applicant Hunan Vathin Medical Instrument Co., Ltd.

K-Number K242535

View Details →

NGL 2024-12-17

Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup

Applicant Healgen Scientific,, LLC

K-Number K243365

View Details →

FGE 2024-12-17

Tornus ES

Applicant Asahi Intecc Co., Ltd.

K-Number K241801

View Details →

PSY 2024-12-17

Roche Digital Pathology Dx

Applicant Ventana Medical Systems, Inc.

K-Number K242783

View Details →

QLQ 2024-12-17

prodisc® L Instruments

Applicant Centinel Spine, LLC

K-Number K242869

View Details →

HHW 2024-12-17

Cntrl+ Bladder Support Pessary

Applicant Cntrl+, Inc.

K-Number K240798

View Details →

HKI 2024-12-17

Sentinel Camera

Applicant Ai Optics

K-Number K243664

View Details →

EBI 2024-12-17

Lucitone Digital Print Denture™ System

Applicant Dentsply Sirona, Inc.

K-Number K243336

View Details →

EBF 2024-12-17

Quantium

Applicant Bisco, Inc.

K-Number K242816

View Details →

KGN 2024-12-17

BIOBRANE Temporary Wound Dressing; BIOBRANE Glove

Applicant Smith & Nephew Medical Limited

K-Number K242146

View Details →

JOJ 2024-12-17

Autoclave Indicator Tape; EO Indicator Tape

Applicant Jiangmen New Era External Use Drug Co., Ltd.

K-Number K241036

View Details →

Page 460 of 2738

↑