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

Inverness, IL, US

Medtrol, Inc. appears in FDA device records in Inverness, IL. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of , FDA records show one recall for this company.

FDA records held for this company

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

510(k) clearance history

FDA records hold 1 510(k) clearance for Medtrol, Inc. in 1996.

Clearances by year, as a table
510(k) clearance decisions for Medtrol, Inc., by decision year
YearClearances
19961
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K953707MEDTROL DENTAL KITEKJSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1815-2010CaviBleach Wipes; a disinfectant medical device, active ingredient Sodium hypochlorite 0.525%; a single 9" x 9" towelette, pre-moistened with 0.525% - 0.656% sodium hypochlorite, packaged in a flexible poly foil pouch, 50 wipes per dispenser box, 8 boxes per case; Manufactured for Metrex Research Corporation, 28210 Wick Road, Romulus, MI 48174. General purpose disinfectant wipe for hard, non-porous surfaces, patient care equipment and point of care equipment.The disinfectant wipes were found out of specifications for the disinfectant activity prior to the expiration date.Terminated

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