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

Indianapolis, IN, US

MICROMED, LLC appears in FDA device records in Indianapolis, IN. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
7
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 7 510(k) clearances for MicroMed, LLC between 1987 and 2021. The busiest year on record is 2018, with 2. The most recent is 2021, with 1.

Clearances by year, as a table
510(k) clearance decisions for MicroMed, LLC, by decision year
YearClearances
19871
19891
19911
20081
20182
20211
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K211974LED PHOTIC SystemGWESubstantially Equivalent
K180761SD LTM STIM Cortical StimulatorGYCSubstantially Equivalent
K171384Micromed BRAIN QUICK systemGWQSubstantially Equivalent
K071782MICROMED BRAIN SPY PLUS, EMBIA TITANIUM DEVICESOLVSubstantially Equivalent
K914762MICRO MED INC. QRS-CARD(TM) OFFICE ECG MONITORDPSSubstantially Equivalent
K882980REBUILDER BUCKET SYSTEMGZJSubstantially Equivalent
K874085REBUILDER(TM)GZJSubstantially Equivalent

Registered establishments

FDA registered establishments for MicroMed, LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30304130773030413077MICROMED, LLC8730 Commerce Park Place, Indianapolis, IN 46268 US2026No device listings on this registration

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

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2353-2026SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02, 2022.01 or 2022.02Natus has become aware of two complaints related to the SD LTM 64 PLUS where the EEG traces acquired from two or four different amplifiers used in a multiple amplifier configuration (128 or 256 channels) running firmware version 2022.02 were displayed with a shift of 1 second between the 64channels blocks. In rare circumstances, a fixed 1-second temporal delay may appear between two 64-channel modules with firmware 2021.02, 2022.01 or 2022.02 in a multi-module SEEG configuration, potentially leading to misinterpretation of results.Class IIOpen, Classified

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

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