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

IOR 1983-08-01

AMBULIZER MODEL MC-5

Applicant Mobilizer Medical Products, Inc.

K-Number K832161

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ESD 1983-08-01

PHONIC EAR PE 845PPC-D

Applicant Phonic Ear, Inc.

K-Number K832081

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JTC 1983-08-01

PIPETTE 12 CHANNEL

Applicant Organon Teknika Corp.

K-Number K831644

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LCP 1983-08-01

CLINOVATIVE II DIAGNOSTIC KIT

Applicant Pierce Chemical Co.

K-Number K831837

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ILH 1983-08-01

SPLINT WOOD

Applicant Vermont Wood Industries, Inc.

K-Number K832144

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EPF 1983-08-01

PHONIC EAR PE 467R-PE 461T

Applicant Phonic Ear, Inc.

K-Number K832080

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HPT 1983-08-01

DICON GLAUCOMA DIAG. CENTER 2000 SERIES

Applicant CooperVision, Inc.

K-Number K832142

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HKP 1983-08-01

CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA

Applicant CooperVision, Inc.

K-Number K832074

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DIP 1983-08-01

EMIT AED PHENYTOIN ASSAY

Applicant Syva Co.

K-Number K832033

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JQC 1983-07-29

LKB 2164 MACRO-SPIN R CENTRIFUGE

Applicant Lkb Instruments, Inc.

K-Number K831942

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JQC 1983-07-29

LKB 2161 MIDISPIN R CENTRIFUGE

Applicant Lkb Instruments, Inc.

K-Number K831948

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KER 1983-07-29

EMBEDDING RING

Applicant Polymer Technology Corp.

K-Number K831922

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