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

JSH 1980-12-22

TRYPTICASE SOY AGAR W/5% RABBIT BLD. CEL

Applicant Sacks Farms Biological Products

K-Number K802994

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CFJ 1980-12-22

SERALYZER LDH REAGENT STRIPS, CALIBR

Applicant Miles Laboratories, Inc.

K-Number K803019

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CAN 1980-12-22

EMERG. OXYGEN KIT #65350 & #65399 CASE

Applicant B & F Medical Products, Inc.

K-Number K802644

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JTZ 1980-12-22

MUELLER HINTON BROTH

Applicant Gibco Laboratories Life Technologies, Inc.

K-Number K802957

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HPX 1980-12-22

KERATOPLASTY SUTURING LENS

Applicant Paris Contact Lens Laboratory

K-Number K802593

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IPY 1980-12-22

CRUSADER HYPEREXTENSION BRACE

Applicant Orthomedics

K-Number K803033

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LCS 1980-12-22

I-125 LABELED DIGOXIN

Applicant Pcl-Ria, Inc.

K-Number K803047

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FIF 1980-12-22

BELLCO SINGLE NEEDLE DOUBLE HEAD PUMP

Applicant Cardio Med Supplies, Inc.

K-Number K802230

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KDC 1980-12-22

COBE CENTRY 2 VARIABLE CONCENTRATE-18-

Applicant Cobe Laboratories, Inc.

K-Number K802895

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BYP 1980-12-22

SHELL KRATON THERMO-PLASTIC RUBBER COMP.

Applicant Warren E. Collins, Inc.

K-Number K803069

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DXY 1980-12-22

MICROTHIN-PII BIPOLAR PULSE GEN. #0621

Applicant Cardiac Pacemakers, Inc.

K-Number K803035

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EXB 1980-12-22

VANCE UROSTOMY APPLIANCE

Applicant Vance Products, Inc.

K-Number K803048

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