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

BXX 1980-06-04

NEEDLE COUNTER-SURE COUNT-DISPOSA-TRAY

Applicant Kleen Test Products

K-Number K801256

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BXX 1980-06-04

NEEDLE COUNTER-SURE COUNT/30 CT. MAGN.

Applicant Kleen Test Products

K-Number K801257

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BSJ 1980-06-04

NON-CONDUCTIVE, SINGLE USE FACE MASK #55

Applicant Vital Signs, Inc.

K-Number K801251

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DTM 1980-06-04

PEDIATRIC ARTERIAL BLOOD FILTER #AF-5

Applicant Bentley Laboratories, Inc.

K-Number K801147

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ESD 1980-06-04

OMNITON MT80-A BODY HEARING AID

Applicant Bosch Hearing Instruments, Inc.

K-Number K800779

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BSF 1980-06-04

PENLON JUMBO CARBON DIOXIDE ABSORBER

Applicant Penlon, Inc.

K-Number K801255

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CBT 1980-06-04

SAMPLING KIT

Applicant Pharmaseal Laboratories

K-Number K801146

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IYO 1980-06-04

EDP 1200 ULTRASONIC B-SCANNER

Applicant Technicare Corp.

K-Number K801056

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JSG 1980-06-02

TRYPTICASE SOY AGAR W5% SHEEP BLOOD

Applicant Quality Assurance Laboratory, Inc.

K-Number K800986

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JXB 1980-06-02

CAPIK-CANDIDA ALBICANS IDENT. KIT.

Applicant Immuno-Mycologics, Inc.

K-Number K800908

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JTC 1980-06-02

DYNAWASHER II

Applicant Dynatech Laboratories, Inc.

K-Number K800989

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KYX 1980-06-02

MULTI-AD FLUID DISPENSING PUMP MP-3000

Applicant Burron Medical Products, Inc.

K-Number K801008

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