Apex Medical Corp.

FDA Regulatory Profile

Apex Medical Corp. has 0 FDA recalls, 0 inspections, 36 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
Jun 28, 2022

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances36Oct 4, 2026Not statedCurrent
Inspections0Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K213577VenAir, Sequential Compression SystemJun 28, 2022
K193206WiZARD 510 Nasal MaskOct 29, 2020
K182394WiZARD 310/320 Series CPAP MaskMay 17, 2019
K150111Apex Medical Corp. iCH CPAP with PVA 9S-007XXX SeriesSep 15, 2015
K141522APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIESOct 6, 2014
K121642WIZARD 230 NASAL PILOW MASKJun 6, 2013
K112079APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720Dec 6, 2012
K120035APEX MEDICAL ICH CPAP SERIES (9S-007XXX)May 16, 2012
K103174APEX MEDICAL WIZARD SERIES CPAP MASKMay 6, 2011
K103535VACPLUS SUCTION UNITFeb 24, 2011
K083656APEX MEDICAL XT AUTO CPAP 9S-005200Apr 22, 2009
K070990APEX MEDICAL MOBINEB, 9R-027 SERIESMay 18, 2007
K070609APEX MEDICAL XT1 CPAP, MODEL 9S-005May 4, 2007
K062664HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004Dec 6, 2006
K050104APEX MEDICAL MININEB & MINIPLUSFeb 16, 2005
K041828APEX MEDICAL CPAP MODEL 9S-003Jul 30, 2004
K022650APEX MEDICAL CPAP RT 21XXFeb 4, 2004
K021754APEX MEDICAL DIGITAL EMS TS1311, TS1312Jun 28, 2002
K021755APEX MEDICAL DIGITAL TENS TS1211, TS1212Jun 12, 2002
K020032APEX MEDICAL MINI TENSJan 31, 2002