APEX MEDICAL TECHNOLOGIES, INC.

Matched from indexed company URL: APEX MEDICAL, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2025773	2025773	APEX MEDICAL TECHNOLOGIES, INC.	1	N	2026-01-01	10064 Mesa Ridge Ct Ste 202 SAN DIEGO CA US 92121
3005583187	3005583187	APEX MEDICAL, INC.	1	N	2026-01-01	105 Quaker Ln Malvern PA US 19355
3006339858	3006339858	Apex Medical (Kunshan) Corp.	1	N	2026-01-01	No.1368, Zi Zhu Rd. Kunshan Kai Fa Hi-Tech, Kunshan City Jiangsu CN 215316
3043861840	3043861840	APEX MEDICAL SOLUTIONS LLC	1	N	2026-01-01	106 Gore Rd Knoxville TN US 37919

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00862242000305	Hy-GeneTM Seminal Fluid Collection Kit - Specimen Collection Container for the collection of semen.	858-535-0012	sales@apexfertility.com
00862242000312	Hy-GeneTM Seminal Fluid Collection Kit - Specimen Collection Container for the collection of semen.	858-535-0012	sales@apexfertility.com
00862242000336	Male-FactorPakTM - Specimen Collection Container used to collect semen.	858-535-0012	sales@apexfertility.com
00862242000367	EndosacTM - Specimen Collection Container	858-535-0216	sales@zenithmedical.com
10862242000364	EndosacTM - Specimen Collection Container	858-535-0216	sales@zenithmedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
34605	1259529106	K954791	SEMINAL FLUID COLLECTION KIT II	HIS	1996-01-05
34605	1607987905	K930313	APEX SPECIMEN BAG	LIO	1993-03-18
83678	1563150947	K251466	VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr	JOW	2025-10-28
83678	2021129104
83678	1071763145
34605	1092717550
34605	1181881840
83678	1225168618
87206	1592408840
83678	1608805463
348763	1860907706
34605	1890652296
34605	2023843466

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
JOW	1	2025-10-28
HIS	1	1996-01-05
LIO	1	1993-03-18

PMN#

VenAir, Sequential Compression System

2022-06-28

Apex Medical Corp.

WiZARD 510 Nasal Mask

2020-10-29

Apex Medical Corp.

WiZARD 310/320 Series CPAP Mask

2019-05-17

Apex Medical Corp.

Apex Medical Corp. ICH CPAP With PVA 9S-007XXX Series

2015-09-15

APEX MEDICAL CORP.

APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES

2014-10-06

APEX MEDICAL CORP.

WIZARD 230 NASAL PILOW MASK

2013-06-06

APEX MEDICAL CORP.

APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720

2012-12-06

APEX MEDICAL CORP.

RHEA CUP

2012-05-24

APEX MEDICAL TECHNOLOGIES, INC.

APEX MEDICAL ICH CPAP SERIES (9S-007XXX)

2012-05-16

APEX MEDICAL CORP.

APEX MEDICAL WIZARD SERIES CPAP MASK

2011-05-06

APEX MEDICAL CORP.

VACPLUS SUCTION UNIT

2011-02-24

APEX MEDICAL CORP.

APEX MEDICAL XT AUTO CPAP 9S-005200

2009-04-22

APEX MEDICAL CORP.

APEX MEDICAL MOBINEB, 9R-027 SERIES

2007-05-18

APEX MEDICAL CORP.

APEX MEDICAL XT1 CPAP, MODEL 9S-005

2007-05-04

APEX MEDICAL CORP.

HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004

2006-12-06

APEX MEDICAL CORP.

SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM

2006-05-09

APEX MEDICAL TECHNOLOGIES, INC.

APEX MEDICAL MININEB & MINIPLUS

2005-02-16

APEX MEDICAL CORP.

APEX MEDICAL DIGITAL TENS TS1211, TS1212

2002-06-12

APEX MEDICAL CORP.

MODIFICATION TO:APEX MEDICAL IF-4100

2001-12-14

APEX MEDICAL CORP.

APEX MEDICAL LCD TENS-VII

2001-10-29

APEX MEDICAL CORP.

COM-PATCH

2001-10-05

APEX MEDICAL CORP.

AEMS V, EMS-1000, MODEL TS-140500 AND AEMS VI, EMS-1000 PLUS, MODEL TS-140600

2001-08-24

APEX MEDICAL CORP.

MS104A, NEWMINI II (EMS-II), MODEL AP-101050T AND MEDTRIM (EMS-V), MODEL AP-102050T

2001-07-27

APEX MEDICAL CORP.

BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100

2000-06-05

APEX MEDICAL CORP.

MICRO II MICROCURRENT TENS

1998-07-29

APEX MEDICAL CORP.

MULTI-STIM TENS, AP-101081T

1998-07-29

APEX MEDICAL CORP.

ACU-STIM TENS, AP-101082T

1998-07-29

APEX MEDICAL CORP.

RAPID FIRE HAIR IMPLANTER CAROUSEL

1997-10-27

APEX MEDICAL PRODUCTS, LLC.

BIOSCOPE SD TENS, ARISTA SD PLUS, AP-102080T

1997-04-29

APEX MEDICAL CORP.

SEMINAL FLUID COLLECTION KIT II

1996-01-05

APEX MEDICAL TECHNOLOGIES, INC.

EXTRA PROTECTION POLYURETHANE CONDOM

1995-05-04

APEX MEDICAL TECHNOLOGIES, INC.

APEX MEDICAL AIR PUMPS

1994-03-17

APEX MEDICAL, INC.

APEX SPECIMEN BAG

1993-03-18

APEX MEDICAL TECHNOLOGIES, INC.

COM-TENS: A NEUROSTIMULATOR

1991-05-30

APEX MEDICAL, INC.

POLYURETHANE CONDOM

1991-03-06

APEX MEDICAL TECHNOLOGIES, INC.

PULSAR EM

1989-04-27

APEX MEDICAL, INC.

SENSATIONS BRAND CONDOMS

1989-03-01

APEX MEDICAL TECHNOLOGIES, INC.

ELIMINATOR AIR FILTER

1988-08-29

APEX MEDICAL, INC.

HI-TOUCH (TM) BRAND SURGICAL GLOVES

1987-12-14

APEX MEDICAL TECHNOLOGIES, INC.

APEX ALPHA VACUUM PUMP

1987-08-18

APEX MEDICAL, INC.

41 records. Showing 1-40. Next

GUDID#

Hy-GeneTM Seminal Fluid Collection Kit - Specimen Collection Container for the collection of semen.

APEX MEDICAL TECHNOLOGIES, INC.

2024-09-05

EndosacTM - Specimen Collection Container

APEX MEDICAL TECHNOLOGIES, INC.

2024-09-05

Hy-GeneTM Seminal Fluid Collection Kit - Specimen Collection Container for the collection of semen.

APEX MEDICAL TECHNOLOGIES, INC.

2024-09-05

EndosacTM - Specimen Collection Container

APEX MEDICAL TECHNOLOGIES, INC.

2024-09-05

Male-FactorPakTM - Specimen Collection Container used to collect semen.

APEX MEDICAL TECHNOLOGIES, INC.

2024-09-05

APEX - WIZARD 510 Nasal Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. The nasal mask is intended for single-patient reuse in the home and multi-patient, multi-use in the hospital environment. The nasal mask is to be used on patients greater than 30 kg for whom positive airway pressure (CPAP or bi-level system) has been prescribed.

APEX MEDICAL CORP.

2022-07-11

APEX - Full Face Mask with Headgear (M size)

APEX MEDICAL CORP.

2019-07-01

APEX - Full Face Mask with Headgear (S size)

APEX MEDICAL CORP.

2019-07-01

APEX - Full Face Mask with Headgear (L size)

APEX MEDICAL CORP.

2019-07-01

APEX - Nasal Mask with Headgear (S size)

APEX MEDICAL CORP.

2019-07-01

APEX - Nasal Mask with Headgear (M size)

APEX MEDICAL CORP.

2019-07-01

APEX - Domus 1 with 2.5" Bubble Pad

APEX MEDICAL CORP.

2018-07-04

APEX - Domus 2s with 5" One Piece Pad

APEX MEDICAL CORP.

2018-07-04

APEX - Serene with 8"+2" Mattress

APEX MEDICAL CORP.

2018-07-04

APEX - Sedens 500 Dynamics with 4" Cushion

APEX MEDICAL CORP.

2018-07-04

APEX - Domus 3 with 8" Mattress

APEX MEDICAL CORP.

2018-07-04

APEX - Domus 3 with 5"+3" Mattress

APEX MEDICAL CORP.

2018-07-04

APEX - Serene Bariatric with 8"+2" Mattress

APEX MEDICAL CORP.

2018-07-04

APEX - Serene Elite with 8" Mattress

APEX MEDICAL CORP.

2018-07-04

APEX - XT Sense with Humidifier

APEX MEDICAL CORP.

2016-09-23

APEX - XT Fit with Humidifier

APEX MEDICAL CORP.

2016-09-23

APEX - Nasal Mask with Headgear (L)

APEX MEDICAL CORP.

2016-09-23

APEX - Full Face Mask w/o Headgear (LW)

APEX MEDICAL CORP.

2016-09-23

APEX - Full Face Mask w/o Headgear (SW)

APEX MEDICAL CORP.

2016-09-23

APEX - Nasal Mask w/o Headgear (XS)

APEX MEDICAL CORP.

2016-09-23

APEX - Nasal Pillows Mask with Headgear (Mr.: S, M, L)

APEX MEDICAL CORP.

2016-09-23

APEX - Full Face Mask with Headgear (SW)

APEX MEDICAL CORP.

2016-09-23

APEX - Full Face Mask with Headgear (S)

APEX MEDICAL CORP.

2016-09-23

APEX - Full Face Mask with Headgear (M)

APEX MEDICAL CORP.

2016-09-23

APEX - Full Face Mask with Headgear (L)

APEX MEDICAL CORP.

2016-09-23

APEX - Nasal Mask with Headgear (XS)

APEX MEDICAL CORP.

2016-09-23

APEX - Nasal Mask with Headgear (M)

APEX MEDICAL CORP.

2016-09-23

APEX - Full Face Fitting Kits (SW,MW,LW)

APEX MEDICAL CORP.

2016-09-23

APEX - iCH Sense

APEX MEDICAL CORP.

2016-09-23

APEX - iCH Sense

APEX MEDICAL CORP.

2016-09-23

APEX - iCH Prime

APEX MEDICAL CORP.

2016-09-23

APEX - iCH Auto

APEX MEDICAL CORP.

2016-09-23

APEX - XT Humidifier

APEX MEDICAL CORP.

2016-09-23

APEX - XT Auto with Humidifier

APEX MEDICAL CORP.

2016-09-23

APEX - XT Auto

APEX MEDICAL CORP.

2016-09-23

42 records. Showing 1-40. Next