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

IYO 1981-03-05

MARK 500 SYSTEM

Applicant Advanced Technology Laboratories, Inc.

K-Number K810073

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KRJ 1981-03-05

PRE-BYPASS FILTER

Applicant Texas Medical Products, Inc.

K-Number K810395

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DQO 1981-03-05

USCI CARDIOVASCULAR CATHETER

Applicant C.R. Bard, Inc.

K-Number K810412

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DSY 1981-03-05

MEADOX SZILAGYI GRAFT

Applicant Meadox Medicals, Div. Boston Scientific Corp.

K-Number K810376

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DTN 1981-03-05

CPS-1000

Applicant Gics Pharmaceuticals

K-Number K802890

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DXY 1981-03-05

STERILE PACKAGING

Applicant Telectronics, Inc.

K-Number K810410

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DXG 1981-03-05

AM 420 MICROPROCESSOR

Applicant Honeywell, Inc.

K-Number K810163

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GAA 1981-03-05

PHERESIS NEEDLE ASSEMBLY

Applicant Haemonetics Corp.

K-Number K810076

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LEJ 1981-03-05

FANCY TAN SUNBED

Applicant Fancy Tan, Inc.

K-Number K810366

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JDO 1981-03-05

PROXIMAL FERMORAL HIP REPLACEMENT

Applicant Biomet, Inc.

K-Number K810258

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IQI 1981-03-04

LIMB ORTHOSIS

Applicant Fred Sammons, Inc.

K-Number K810443

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ESD 1981-03-04

EARETTE HEARING AID SEARS MODEL 8053

Applicant Oticon Corp.

K-Number K810389

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