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

GKR 1983-06-16

HEMOGLOBIN REAGENT

Applicant Omega Medical Diagnostics

K-Number K831618

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GIF 1983-06-16

DILUENT

Applicant Omega Medical Diagnostics

K-Number K831617

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CEW 1983-06-16

DAC-CEL PTH KIT RD51

Applicant Wellcome Diagnostics

K-Number K831069

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LAS 1983-06-16

EMIT QST TOBRAMYCIN CONTROL

Applicant Syva Co.

K-Number K831417

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BXB 1983-06-16

PATIENT GUIDED ELBOW & SHOULDER EXERC

Applicant Richard'S Medical Equip., Inc.

K-Number K830793

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EQH 1983-06-16

VENT TUBE FORCEPS

Applicant Treace Medical, Inc.

K-Number K831589

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DJY 1983-06-16

PREFILLED IEC COLUMNS

Applicant Berwick Medical Products, Inc.

K-Number K831289

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GDW 1983-06-15

APPOSE SKIN STAPLER & REMOVER

Applicant American Cyanamid Co.

K-Number K823552

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KNC 1983-06-15

DELIVERY 4 TABLE

Applicant Amsco Co.

K-Number K831309

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DXQ 1983-06-15

METAL-BACKED ACETABULAR CUP

Applicant Dow Corning Corp. Healthcare Industries Materials

K-Number K831479

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DXG 1983-06-15

THERMODILUTION CARDIAC OUTPUT COMPUTER-

Applicant American Edwards Laboratories

K-Number K830892

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IQK 1983-06-15

VARI-SUPPORT NECK POSTURE PILLOW

Applicant Body Therapeutics, Inc.

K-Number K831582

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