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

IPF 1980-05-02

MOD. 3127 NEUROMUSCULAR STIMULATOR

Applicant Medtronic Vascular

K-Number K800484

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JDS 1980-05-02

SILASTIC BONE PLUG H.P.(CEMENT RESTRICT)

Applicant Dow Corning Corp. Healthcare Industries Materials

K-Number K800898

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DXY 1980-05-02

PULSE GENERATORS MODELS 657 & 677

Applicant Siemens Elema AB

K-Number K800387

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ITG 1980-05-02

BVN

Applicant Donald J. Mangus, M.D.

K-Number K800695

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JSI 1980-05-02

CELLIBIOSE-ARGININE-LYSINE AGAR (CAL)

Applicant Remel Co.

K-Number K800745

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KTC 1980-05-02

PERSONAL SITZ BATH KIT

Applicant The Healthcare Group Laboratories, Inc.

K-Number K800958

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N/A 1980-05-02

SUNHOUSE UVB ULTRAVIOLET LIGHT TANNING

Applicant Progressive Productions , Ltd.

K-Number K800697

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FJI 1980-05-02

GAMBRO LUNDIA FIBER

Applicant Gambro, Inc.

K-Number K800336

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EJS 1980-05-02

AUSTRY ALLOY(DENTAL BAKE-ON ALLOY)

Applicant Howmedica Corp.

K-Number K800994

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N/A 1980-05-02

MEDSPEC RUBBER BANDS

Applicant Medspec Corp.

K-Number K800279

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IME 1980-05-02

TRU-COLD THERAPY PAK

Applicant Tru-Eze Mfg. Co., Inc.

K-Number K800917

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IYO 1980-05-02

4200 ME ECHOENCEPHALOGRAPH

Applicant Kt Medical, Inc.

K-Number K800101

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