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

HRX 1983-08-16

ACUFLEX LEVY ACL DRILL GUIDE SYS

Applicant Acufex Microsurgical, Inc.

K-Number K832277

View Details →

CEK 1983-08-16

TOTAL PROTEIN PROCEDURE

Applicant Sandare Chemical Co., Inc.

K-Number K832169

View Details →

N/A 1983-08-16

SCOLIOMETER

Applicant Orthopedic Systems, Inc.

K-Number K832494

View Details →

DXZ 1983-08-13

VASCULAR GRAFT/BIFURCATED/FEP-RINGED

Applicant W. L. Gore & Associates, Inc.

K-Number K830806

View Details →

KMY 1983-08-12

AQUALIZER MOUTHPIECE

Applicant Martin D. Lerman

K-Number K831793

View Details →

LAN 1983-08-12

N-ACETYLPROCAINAMIDE ASSAY FOR COBAS

Applicant Syva Co.

K-Number K832098

View Details →

FPB 1983-08-12

IVFLO-HP & IVFIL-HP FILTER

Applicant Tri-Med, Inc.

K-Number K831350

View Details →

BZG 1983-08-12

OHIO MODEL 922 SPIROMETER

Applicant Airco/Ohio Medical Products

K-Number K832185

View Details →

NAB 1983-08-12

BANDAGE COMPRESS

Applicant Pac-Kit Safety Equipment Co.

K-Number K831282

View Details →

MRD 1983-08-12

CUI MAMMARY PROTHESIS SIZER

Applicant Cox-Uphuff Intl.

K-Number K831566

View Details →

LIT 1983-08-12

FOGARTY-CHIN PERIPHERAL INTRAOPERATIVE

Applicant American Edwards Laboratories

K-Number K831659

View Details →

FTM 1983-08-12

QUARTER GLOBE CAPS

Applicant S. Jackson, Inc.

K-Number K831727

View Details →

Page 12544 of 14156

↑