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

FKR 1981-06-16

CHEMATIC BICARBONATE DIALYSATE SYSTEM

Applicant Trimedyne, Inc.

K-Number K810605

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EJH 1981-06-16

BA-93

Applicant Deringer-Ney, Inc.

K-Number K811407

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GEH 1981-06-16

CCS100 CRYOSURGICAL SYSTEM

Applicant Frigitronics of Connecticut, Inc.

K-Number K811390

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JSX 1981-06-16

NEISSERIA-KWIK

Applicant Windsor Laboratories, Inc.

K-Number K811412

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DXY 1981-06-16

#325 PROGRAMMABLE CARD. PULSE GENERATOR

Applicant Cook Pacemaker Corp.

K-Number K810884

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EGY 1981-06-16

YOSHIDA AP 100

Applicant Kaycor Intl., Ltd.

K-Number K811211

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ESD 1981-06-16

HEARING AID MODEL E1-P

Applicant Unitron Industries, Inc.

K-Number K811285

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JTN 1981-06-16

PARA-PAK

Applicant Meridian Diagnostics, Inc.

K-Number K811377

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HJO 1981-06-16

COHERENT FLOUROTRON MASTER

Applicant Lumenis, Inc.

K-Number K811153

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DHL 1981-06-16

SCRIPPSERA COMPLEMENT CONTROL SERA

Applicant Scripps-Miles, Inc.

K-Number K811433

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ESD 1981-06-16

BEHIND-THE-EAR HEARING AID

Applicant Maico Hearing Instruments, Inc.

K-Number K811344

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DSI 1981-06-16

CC-103

Applicant Anthro-Metrics Corp.

K-Number K811527

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