510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Duoject Medical Systems, Inc.

BROMONT Quebec, CA

DUOJECT MEDICAL SYSTEMS, INC. appears in FDA device records in BROMONT Quebec, CA. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
3
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 3 510(k) clearances for Duoject Medical Systems, Inc. between 2001 and 2014. The busiest year on record is 2001, with 1. The most recent is 2014, with 1.

Clearances by year, as a table
510(k) clearance decisions for Duoject Medical Systems, Inc., by decision year
YearClearances
20011
20081
20141
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K133097E-Z LINKLHISubstantially Equivalent
K070584SMART-RODLHISubstantially Equivalent
K010703INTER-VIALLHISubstantially Equivalent

Registered establishments

FDA registered establishments for Duoject Medical Systems, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96137443002771638DUOJECT MEDICAL SYSTEMS, INC.50 CHEMIN DE GASPE, BROMONT Quebec J2L 2N8 CA2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain