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

KPO 1980-07-14

LOW-ACETATE HEMODIALYSIS BATH CONCENTR.

Applicant Travenol Laboratories, S.A.

K-Number K800624

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JHI 1980-07-14

GAMMADAB B-HCG RADIOIMMUNOASSAY KIT

Applicant Travenol Laboratories, S.A.

K-Number K801409

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KSS 1980-07-14

PRE-DENT SYSTEM MODIFIED

Applicant Pre-Dent System

K-Number K801516

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JHX 1980-07-14

HELENA ULTRA SENSITIVE CPK REAGENT/DILUE

Applicant Helena Laboratories

K-Number K801318

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GAG 1980-07-14

SKIN STAPLER HANDLE 523700/CARTRIDGES

Applicant Edward Weck, Inc.

K-Number K801445

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JPK 1980-07-14

RED BLOOD CELL COUNT & HEMATOCRIT CNTL

Applicant Bioscientific

K-Number K801267

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JZW 1980-07-14

DISC 120 TRANSPORTER

Applicant Travenol Laboratories, S.A.

K-Number K801391

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JTC 1980-07-14

DISPENSING SEROLOGICAL PIPET

Applicant Amt Corp.

K-Number K801437

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GGW 1980-07-14

ANTIBODY TO VARICELLA-ZOSTER VIRUS

Applicant Electro-Nucleonics Laboratories, Inc.

K-Number K800787

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BYX 1980-07-14

TIMETER PRODUCED PURRITAN BENNETT O2 ADP

Applicant Timeter Instrument Corp.

K-Number K801514

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GCY 1980-07-14

P-S SURGICAL DRAIN

Applicant Pudenz-Schulte Medical Research Corp.

K-Number K801442

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DRS 1980-07-14

STERILE, DISP DOME, INDIVID. PKG.

Applicant Pacific Domes, Inc.

K-Number K801239

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