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

Murrysville, PA, US

Childrens Medical Ventures, LLC appears in FDA device records in Murrysville, PA. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
2
Registered establishments
0

510(k) clearance history

FDA records hold 1 510(k) clearance for Childrens Medical Ventures, LLC in 2011.

Clearances by year, as a table
510(k) clearance decisions for Childrens Medical Ventures, LLC, by decision year
YearClearances
20111
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K103410NEOPAP SYSTEMBZDSubstantially 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-2192-2014Gel-E Donut, Squishon 2 gel pillows Product Usage:: The products are intended to support and cradle a baby s head and/or body. The rectangular shape of the Squishon product allows for head movement while maintaining a supportive surface and provides an effective ventral support for prone positioning. The round shape of the Gel-E Donut products help alleviate pressure caused by prolonged immobility or other conditions where frequent repositioning is contraindicated.The gel-filled Gel-E Donut and Squishon product line has received a number of complaints about visible mold. The mold detected was determined to be Cladosporium and Penicillium Fungi, which are commonly found molds.Class ITerminated
Z-1789-2014Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor.The battery pack wire harness is improperly assembled rendering the device inoperable. The wiring issue causes an error code to be displayed and results in the device sounding an alarm repeatedly at power up. The presence of the error code and the devices alarm prevents the device from functioning until the issue is addressed.Class IITerminated

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