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

MARKHAM Ontario, CA

DIROS TECHNOLOGY, INC. appears in FDA device records in MARKHAM Ontario, CA. FDA records list 8 510(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
8
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 8 510(k) clearances for Diros Technology, Inc. between 2002 and 2017. The busiest year on record is 2011, with 2. The most recent is 2017, with 1.

Clearances by year, as a table
510(k) clearance decisions for Diros Technology, Inc., by decision year
YearClearances
20021
20061
20101
20112
20141
20151
20171
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K170708OWL RF INSULATED CANNULAEGXISubstantially Equivalent
K150371Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRHGXISubstantially Equivalent
K141586OWL CANNULAEGXISubstantially Equivalent
K102566OWL CANNULAEGXISubstantially Equivalent
K110593OWL RF PROBESGXISubstantially Equivalent
K093185OWL UNIVERSAL RF SYSTEM URF-3AP (ML)GXDSubstantially Equivalent
K062758OWL URF-3APGXDSubstantially Equivalent
K021869OWL RADIOFREQUENCY SYSTEM, MODEL URF-2APGXDSubstantially Equivalent

Registered establishments

FDA registered establishments for Diros Technology, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
80433983003630373DIROS TECHNOLOGY, INC.120 GIBSON DRIVE, MARKHAM Ontario L3R 2Z3 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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What MDM checks, and what it does not

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