Company ยท TW
Apex Medical Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1987 to 2022. Name variants (Inc, Corp, punctuation) are merged.
36510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | 12 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 8 |
| CAF | Nebulizer (Direct Patient Interface) | 3 |
| IPF | Stimulator, Muscle, Powered | 3 |
| GXY | Electrode, Cutaneous | 2 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 1 |
| FNM | Mattress, Air Flotation, Alternating Pressure | 1 |
| GEA | Cannula, Surgical, General & Plastic Surgery | 1 |
| ILX | Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat | 1 |
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | 1 |
| JOW | Sleeve, Limb, Compressible | 1 |
| KDQ | Bottle, Collection, Vacuum | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 28, 2022 | K213577 | VenAir, Sequential Compression System Apex Medical Corp., TW | JOW |
| Oct 29, 2020 | K193206 | WiZARD 510 Nasal Mask Apex Medical Corp., TW | BZD |
| May 17, 2019 | K182394 | WiZARD 310/320 Series CPAP Mask Apex Medical Corp., TW | BZD |
| Sep 15, 2015 | K150111 | Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series Apex Medical Corp., TW | BZD |
| Oct 6, 2014 | K141522 | APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES Apex Medical Corp., TW | BZD |
| Jun 6, 2013 | K121642 | WIZARD 230 NASAL PILOW MASK Apex Medical Corp., TW | BZD |
| Dec 6, 2012 | K112079 | APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720 Apex Medical Corp., TW | BZD |
| May 16, 2012 | K120035 | APEX MEDICAL ICH CPAP SERIES (9S-007XXX) Apex Medical Corp., TW | BZD |
| May 6, 2011 | K103174 | APEX MEDICAL WIZARD SERIES CPAP MASK Apex Medical Corp., TW | BZD |
| Feb 24, 2011 | K103535 | VACPLUS SUCTION UNIT Apex Medical Corp., TW | JCX |
| Apr 22, 2009 | K083656 | APEX MEDICAL XT AUTO CPAP 9S-005200 Apex Medical Corp., TW | BZD |
| May 18, 2007 | K070990 | APEX MEDICAL MOBINEB, 9R-027 SERIES Apex Medical Corp., TW | CAF |
| May 4, 2007 | K070609 | APEX MEDICAL XT1 CPAP, MODEL 9S-005 Apex Medical Corp., TW | BZD |
| Dec 6, 2006 | K062664 | HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004 Apex Medical Corp., TW | BTT |
| Feb 16, 2005 | K050104 | APEX MEDICAL MININEB & MINIPLUS Apex Medical Corp., TW | CAF |
| Jul 30, 2004 | K041828 | APEX MEDICAL CPAP MODEL 9S-003 Apex Medical Corp., TW | BZD |
| Feb 4, 2004 | K022650 | APEX MEDICAL CPAP RT 21XX Apex Medical Corp., TW | BZD |
| Jun 28, 2002 | K021754 | APEX MEDICAL DIGITAL EMS TS1311, TS1312 Apex Medical Corp., TW | IPF |
| Jun 12, 2002 | K021755 | APEX MEDICAL DIGITAL TENS TS1211, TS1212 Apex Medical Corp., TW | GZJ |
| Jan 31, 2002 | K020032 | APEX MEDICAL MINI TENS Apex Medical Corp., TW | GZJ |
| Dec 14, 2001 | K013813 | MODIFICATION TO:APEX MEDICAL IF-4100 Apex Medical Corp., TW | GXY |
| Oct 29, 2001 | K012643 | APEX MEDICAL LCD TENS-VII Apex Medical Corp., TW | GZJ |
| Oct 5, 2001 | K012140 | COM-PATCH Apex Medical Corp., TW | GXY |
| Aug 24, 2001 | K002339 | AEMS V, EMS-1000, MODEL TS-140500 AND AEMS VI, EMS-1000 PLUS, MODEL TS-140600 Apex Medical Corp., TW | IPF |
| Jul 27, 2001 | K002336 | MS104A, NEWMINI II (EMS-II), MODEL AP-101050T AND MEDTRIM (EMS-V), MODEL AP-102050T Apex Medical Corp., TW | IPF |
| Jun 5, 2000 | K990435 | BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100 Apex Medical Corp., TW | CAF |
| Jul 29, 1998 | K973980 | ACU-STIM TENS, AP-101082T Apex Medical Corp., TW | GZJ |
| Jul 29, 1998 | K973979 | MULTI-STIM TENS, AP-101081T Apex Medical Corp., TW | GZJ |
| Jul 29, 1998 | K973978 | MICRO II MICROCURRENT TENS Apex Medical Corp., TW | GZJ |
| Apr 29, 1997 | K970429 | BIOSCOPE SD TENS, ARISTA SD PLUS, AP-102080T Apex Medical Corp., TW | GZJ |
| Mar 17, 1994 | K933965 | APEX MEDICAL AIR PUMPS Apex Medical, Inc. | FNM |
| May 30, 1991 | K902102 | COM-TENS: A NEUROSTIMULATOR Apex Medical, Inc. | GZJ |
| Apr 27, 1989 | K882816 | PULSAR EM Apex Medical, Inc. | ILX |
| Aug 29, 1988 | K882468 | ELIMINATOR AIR FILTER Apex Medical, Inc. | KDQ |
| Aug 18, 1987 | K871570 | APEX ALPHA VACUUM PUMP Apex Medical, Inc. | BTA |
| May 22, 1987 | K871384 | APEX SUCTION CURETTE Apex Medical, Inc. | GEA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||