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

Murray Hill, NJ, US

Linde Gas North America, LLC appears in FDA device records in Murray Hill, NJ. 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 Linde Gas North America, LLC in 2011.

Clearances by year, as a table
510(k) clearance decisions for Linde Gas North America, LLC, by decision year
YearClearances
20111
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K101792LIV LINDE INTERGRATED VALVE-PORTABLE OXYGEN SYSTEM, MODEL M706ECXSubstantially 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-1561-2013MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR Imaging for MRI systems up to 3.0 T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only.A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs.Class IITerminated

Verification record

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