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

FEM 1981-10-19

PHOTOGRAPHIC EQUIPMENT

Applicant Reznik Instruments

K-Number K812201

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KDI 1981-10-19

MODEL H12-10

Applicant Hospal Medical Corp.

K-Number K812575

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GZJ 1981-10-19

NEUROMED SELECTRA #7720

Applicant Medtronic Vascular

K-Number K812704

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JHX 1981-10-19

NML CK-MB RIA

Applicant Nuclear Medical Laboratories, Inc.

K-Number K812759

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KDJ 1981-10-19

PERITONEAL DIALYSIS DRAINAGE

Applicant Dravon Medical, Inc.

K-Number K812771

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LBZ 1981-10-19

AMES TDA QUINIDINE TEST

Applicant Miles Laboratories, Inc.

K-Number K812753

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EFQ 1981-10-16

DRESSING CHANGE TRAYS & STERILE SPONGES

Applicant O.R. Specialties, Inc.

K-Number K811951

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JDI 1981-10-14

PROXIMAL INTERPHALANGEAL JOINT IMPLANT

Applicant Sutter Biomedical, Inc.

K-Number K802342

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EWO 1981-10-14

EARSCAN

Applicant Micro Audiometrics Corp.

K-Number K812529

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IPF 1981-10-14

BIO-TONE MODEL 4

Applicant Biotone International, Inc.

K-Number K811737

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EMA 1981-10-14

TEMP-FILL

Applicant Madrid Uso, Jr., D.D.S.

K-Number K812532

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FSM 1981-10-14

OPERATING ROOM KIT

Applicant American Hospital Supply Corp.

K-Number K811916

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