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

KLB 1979-08-16

AMES TDA/TOBRAMYCIN

Applicant Miles Laboratories, Inc.

K-Number K791435

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GSN 1979-08-16

NEGATIVE CONTROL SERUM FOR CF RO ID

Applicant Immuno-Mycologics, Inc.

K-Number K791385

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DFZ 1979-08-16

ANTISERA TO RABBIT IMMUNOGLOBULIN

Applicant Kent Laboratories, Inc.

K-Number K790720

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LFR 1979-08-10

GLUCOSE (GDH) REAGENT

Applicant Gilford Diagnostics

K-Number K791213

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DYH 1979-08-10

SCI-PHARM ORTHODONTIC ADHESIVE

Applicant Scientific Pharmaceuticals, Inc.

K-Number K791132

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IYO 1979-08-10

BRITT LENS COMPUTER

Applicant Britt Corp., Inc.

K-Number K790694

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HQE 1979-08-10

VITRECTOMY INTEGRATING TRAY OCUTOME/FRAG

Applicant Precision Medical Instruments, Inc.

K-Number K791212

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ITI 1979-08-10

MAINSTREAM ELEVATING WHEEL CHAIR

Applicant Summit Services, Inc.

K-Number K791408

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BZG 1979-08-10

DISPIRO

Applicant Utah Medical Products, Inc.

K-Number K791177

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DXY 1979-08-10

BJORK-SHILEY AORTIC GRAFT VALVE PROSTH

Applicant Shiley, Inc.

K-Number K791225

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DXY 1979-08-10

MDL-201A & T DL-201A PULSE GENERATOR

Applicant Pacesetter Systems

K-Number K790428

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DXY 1979-08-10

PULSE GENERATOR, R WAVE DEMAND

Applicant Pacesetter Systems

K-Number K790141

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