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

DJB 1978-03-17

QUANTITOPE 125-I GENTAMICIN RIA KIT

Applicant Kallestad Laboratories, Inc.

K-Number K780323

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FIE 1978-03-17

AVF SET FOR SINGLE NEEDLE HEMODIALYSIS

Applicant Terumo America, Inc.

K-Number K772362

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DSF 1978-03-15

MINYSTAG MN-1

Applicant Lkb Instruments, Inc.

K-Number K780338

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JDO 1978-03-15

NAIL, MASSIE II

Applicant Howmedica Corp.

K-Number K780187

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EJF 1978-03-15

ORTHODONTIC BRACKET PADS

Applicant Rocky Mountain Orthodontics, Inc.

K-Number K780170

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FJI 1978-03-15

DIALYZER, CAPILATORY, HOLLOW FIBER

Applicant Redy Laboratories

K-Number K772290

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MBV 1978-03-15

TIBIAL PLATEU

Applicant Depuy, Inc.

K-Number K780284

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DYW 1978-03-15

BRACKET, METAL REINFORCED PLASTIC

Applicant Ormco Corp.

K-Number K780239

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KYC 1978-03-15

FLUORESOFT

Applicant Holles Laboratories, Inc.

K-Number K780125

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DXN 1978-03-15

ULTRASPHYG BLOOD PRESSURE OPTION

Applicant Cavitron Corp.

K-Number K780046

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IOZ 1978-03-15

PAVLIK HARNESS

Applicant Biomet, Inc.

K-Number K780375

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ELW 1978-03-15

RTV DENTAL SILICONE

Applicant Tydont, Inc.

K-Number K780164

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