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

ESD 1978-04-28

HEARING AID, EARETTE

Applicant Oticon Corp.

K-Number K780654

View Details →

GMD 1978-04-28

CRYPTOCOCCAL ANTIGEN LATEX AGG. SYSTEM

Applicant I M, Inc.

K-Number K780526

View Details →

EHY 1978-04-28

IMPRESSION TRAY

Applicant Rocky Mountain Orthodontics, Inc.

K-Number K780678

View Details →

CEE 1978-04-28

STIKSEP-T3 KIT

Applicant Nuclear Diagnostics, Inc.

K-Number K780486

View Details →

FHA 1978-04-28

CLAMP, INCONTINENCE, BAUMRUCKER

Applicant Greenwald Surgical Co., Inc.

K-Number K780137

View Details →

EFB 1978-04-28

FIBER OPTIC HANDPIECE

Applicant Syntex Corp.

K-Number K780483

View Details →

DWS 1978-04-28

AORTIC PUMP

Applicant ETHICON, Inc.

K-Number K780567

View Details →

DQA 1978-04-28

UNISTAT OXIMETER

Applicant American Optical Corp.

K-Number K780625

View Details →

CEP 1978-04-28

RIA SYS. FOR HUMAN LUTEINIZING HORMONE

Applicant Calbiochem-Behring Corp.

K-Number K780367

View Details →

CKA 1978-04-28

STAC SYSTEM

Applicant Technicon Instruments Corp.

K-Number K780373

View Details →

DJB 1978-04-28

GENTAMICIN RIA KIT

Applicant Antibodies, Inc.

K-Number K780516

View Details →

CAH 1978-04-27

HUMIDIFIER FILTER

Applicant Hudson Oxygen Therapy Sales Co.

K-Number K780535

View Details →

Page 13822 of 14142

↑