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

Burnsville, MN, US

ADVANCED RESEARCH MEDICAL appears in FDA device records in Burnsville, MN. FDA records list 2 510(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
2
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 2 510(k) clearances for Advanced Research Medical between 2018 and 2021. The busiest year on record is 2018, with 1. The most recent is 2021, with 1.

Clearances by year, as a table
510(k) clearance decisions for Advanced Research Medical, by decision year
YearClearances
20181
20211
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K203373Advanced Research Medical Trident SI Screw SystemOURSubstantially Equivalent
K173947Lumbar Interbody Fusion System (OLLIF)MAXSubstantially Equivalent

Registered establishments

FDA registered establishments for Advanced Research Medical, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30160023223016002322ADVANCED RESEARCH MEDICAL1515 HIGHWAY 13 EAST, Burnsville, MN 55337 US2026

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-1698-2024ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4; treatment of degenerative disc diseasePotential shearing of the disposable blade may occur and be contained within the of Flexible Curette Shaft Assembly during surgery.Class IICompleted

Verification record

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