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

DTD 1980-07-21

ADAPTAID HELICAL COIL ADAPTER 365-14

Applicant Intermedics, Inc.

K-Number K801039

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FKT 1980-07-21

SORB 10 DIALYSATE INFUSATE C1 INFUSATE

Applicant Organon Teknika Corp.

K-Number K801440

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CBT 1980-07-21

ASPIRATOR

Applicant Marquest Medical Products, Inc.

K-Number K801620

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BZC 1980-07-21

SURVEYOR I, RESPIRATORY COMPUTER SYSTEM

Applicant The Devilbiss Co.

K-Number K801526

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CBT 1980-07-18

ORGANON ARTERIAL BLOOD SAMPLER

Applicant Akzona, Inc.

K-Number K801435

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KSS 1980-07-14

PRE-DENT SYSTEM OR PRE-DENT II

Applicant Pre-Dent System

K-Number K801386

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GDT 1980-07-14

SKIN STAPLE REMOVER #523770

Applicant Edward Weck, Inc.

K-Number K801444

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KSF 1980-07-14

RH CONTROL

Applicant North American Biologicals, Inc.

K-Number K801425

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DIW 1980-07-14

HI-M-TEST FOR METHADONE TEST #2

Applicant Technam, Inc.

K-Number K801509

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CGS 1980-07-14

COBAS CK-NAC REAGENT

Applicant Roche Analytical Instruments, Inc.

K-Number K801299

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CCW 1980-07-14

OROTRACHEAL INTUBATION ENDOSCOPE

Applicant Olympus Corp.

K-Number K801452

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JJN 1980-07-14

HIPP BUFFER(NON-BARBITAL), P/N

Applicant Gelman Sciences, Inc.

K-Number K801378

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