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

KBF 1980-12-19

MONTG. TRACHEAL TREPHINE FENE STRATOR

Applicant Boston Medical Products, Inc.

K-Number K802915

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GCY 1980-12-19

ISPVAC TM

Applicant Innovative Surgical Products, Inc.

K-Number K802973

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EWO 1980-12-19

101, 151, 161 PORTABLE AUDIOMETERS

Applicant Amplaid USA, Inc.

K-Number K802963

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ETB 1980-12-19

SHEA LOCKING BAIL PROSTHESIS

Applicant Richard'S Medical Equip., Inc.

K-Number K802873

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N/A 1980-12-19

CARBONACRYL

Applicant Ipos Luneburg

K-Number K802976

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N/A 1980-12-19

ABSELE* ABSORBABLE BONE SEALANT

Applicant ETHICON, Inc.

K-Number K802881

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BTO 1980-12-19

MONTG. TRACHEAL CANNULA

Applicant Boston Medical Products, Inc.

K-Number K802916

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LBH 1980-12-19

SCI-PHARM UNIVERSAL CAVITY VARNISH

Applicant Scientific Pharmaceuticals, Inc.

K-Number K802926

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CAH 1980-12-19

6-435 FILTER PAD, 5/PKG.

Applicant Lifecare Services, Inc.

K-Number K802914

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N/A 1980-12-19

IPOCARBON STRETCH STOCKINETTE

Applicant Ipos Luneburg

K-Number K802977

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N/A 1980-12-19

ACCU-COUNTER SURGICAL SPONGE COUNTING SY

Applicant Surgical Systems, Inc.

K-Number K802868

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JRE 1980-12-19

NIKON URINE REFRACTOMER SG-1

Applicant Nippon Kogaku, Inc.

K-Number K802959

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