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

Charlotte, NC, US

Sunnex, Inc. appears in FDA device records in Charlotte, NC. FDA records list 2 510(k) clearances between and , 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
2
PMA records
0
Recall records
2
Registered establishments
0

510(k) clearance history

FDA records hold 2 510(k) clearances for Sunnex, Inc. between 1985 and 2014. The busiest year on record is 1985, with 1. The most recent is 2014, with 1.

Clearances by year, as a table
510(k) clearance decisions for Sunnex, Inc., by decision year
YearClearances
19851
20141
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K142984Leo MinorFSYSubstantially Equivalent
K851511ACCURATECARE I & ACCURATECARE IIGZJSubstantially 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-1101-2007Tri-Star Surgical Exam Light MR-16 ( Lamp Holder) used in the following: Model Numbers: TS2015W (wall mount) , TS2015M (mobile) , TS2015W (wall mount) , TS2035M (mobile)Surgical and/or exam lamp holder may malfunction, discolor, melt and smolder.Terminated
Z-1100-2007Sunnex Celestial Star MR-16 (lamp holder) Medical Examination Lighting used in Model Numbers: CS2050C (ceiling mount), CS2050W (wall mount). CS2050D (dual mount) , CS2050M (mobile).Surgical and/or exam lamp holder may malfunction, discolor, melt and smolder.Terminated

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