Apex Medical Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
36
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K213577VenAir, Sequential Compression SystemJune 28, 2022
K193206WiZARD 510 Nasal MaskOctober 29, 2020
K182394WiZARD 310/320 Series CPAP MaskMay 17, 2019
K150111Apex Medical Corp. iCH CPAP with PVA 9S-007XXX SeriesSeptember 15, 2015
K141522APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIESOctober 6, 2014
K121642WIZARD 230 NASAL PILOW MASKJune 6, 2013
K112079APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720December 6, 2012
K120035APEX MEDICAL ICH CPAP SERIES (9S-007XXX)May 16, 2012
K103174APEX MEDICAL WIZARD SERIES CPAP MASKMay 6, 2011
K103535VACPLUS SUCTION UNITFebruary 24, 2011
K083656APEX MEDICAL XT AUTO CPAP 9S-005200April 22, 2009
K070990APEX MEDICAL MOBINEB, 9R-027 SERIESMay 18, 2007
K070609APEX MEDICAL XT1 CPAP, MODEL 9S-005May 4, 2007
K062664HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004December 6, 2006
K050104APEX MEDICAL MININEB & MINIPLUSFebruary 16, 2005
K041828APEX MEDICAL CPAP MODEL 9S-003July 30, 2004
K022650APEX MEDICAL CPAP RT 21XXFebruary 4, 2004
K021754APEX MEDICAL DIGITAL EMS TS1311, TS1312June 28, 2002
K021755APEX MEDICAL DIGITAL TENS TS1211, TS1212June 12, 2002
K020032APEX MEDICAL MINI TENSJanuary 31, 2002