Kentec Medical Inc

FDA Filings

This page includes the latest FDA filings for Kentec Medical Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 2080225
• FEI Number: 2080225
• Name: KENTEC MEDICAL, INC.
• Owner & Operator: KENTEC MEDICAL, INC.
• Contact Address: 17871 FITCH --; Irvine CA 92614 US
• Official Correspondent:
  • KEITH - ROOKS
  • x-800-8255996-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 17871 FITCH ; Irvine, CA 92614 US
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 20817522013333 KENTEC MEDICAL, INC.	Kentec electrode AMG-503-PED	2024-05-03
GUDID 10817522010939 KENTEC MEDICAL, INC.	Ameritus Transducer RATG-WAVE-U	2022-11-28
GUDID 10817522010922 KENTEC MEDICAL, INC.	Ameritus Transducer RATG-SLIM-TB	2022-11-28
GUDID 10817522010915 KENTEC MEDICAL, INC.	Ameritus Transducer RATG-WAVE-T	2022-11-28
GUDID 10817522010908 KENTEC MEDICAL, INC.	Ameritus Transducer RATG-SLIM-T	2022-11-28
GUDID 10817522010892 KENTEC MEDICAL, INC.	Ameritus Transducer RATG-AVLN-U	2022-11-28
GUDID 10817522010885 KENTEC MEDICAL, INC.	Ameritus Transducer RATG-AVLN-T	2022-11-28
GUDID 10817522010878 KENTEC MEDICAL, INC.	Ameritus Transducer RATG-400-U	2022-11-28
GUDID 10817522010861 KENTEC MEDICAL, INC.	Ameritus Transducer RATG-302-T	2022-11-28
GUDID 10817522010854 KENTEC MEDICAL, INC.	Ameritus Transducer RATG-200-U	2022-11-28
GUDID 10817522010847 KENTEC MEDICAL, INC.	Ameritus Transducer RATG-200-T	2022-11-28
GUDID 10817522010830 KENTEC MEDICAL, INC.	Ameritus Transducer RATG-100-U	2022-11-28
GUDID 10817522010823 KENTEC MEDICAL, INC.	Ameritus Transducer RATG-100-T	2022-11-28
GUDID 10817522010816 KENTEC MEDICAL, INC.	Ameritus Transducer ATG-WAVE-UB	2022-11-28
GUDID 10817522010809 KENTEC MEDICAL, INC.	Ameritus Transducer ATG-WAVE-U	2022-11-28
GUDID 10817522010793 KENTEC MEDICAL, INC.	Ameritus Transducer ATG-WAVE-TB	2022-11-28
GUDID 10817522010786 KENTEC MEDICAL, INC.	Ameritus Transducer ATG-WAVE-T	2022-11-28
GUDID 10817522010779 KENTEC MEDICAL, INC.	Ameritus Transducer ATG-SLIM-TB	2022-11-28
GUDID 10817522010762 KENTEC MEDICAL, INC.	Ameritus Transducer ATG402-TB	2022-11-28
GUDID 10817522010755 KENTEC MEDICAL, INC.	Ameritus Transducer ATG402-T	2022-11-28
GUDID 10817522010748 KENTEC MEDICAL, INC.	Ameritus Transducer ATG400-UB	2022-11-28
GUDID 10817522010731 KENTEC MEDICAL, INC.	Ameritus Transducer ATG400-U	2022-11-28
GUDID 10817522010724 KENTEC MEDICAL, INC.	Ameritus Transducer ATG303-TB	2022-11-28
GUDID 10817522010717 KENTEC MEDICAL, INC.	Ameritus Transducer ATG300-U	2022-11-28
GUDID 10817522010700 KENTEC MEDICAL, INC.	Ameritus Transducer ATG200-U	2022-11-28
GUDID 10817522010694 KENTEC MEDICAL, INC.	Ameritus Transducer ATG200-T	2022-11-28
GUDID 10817522010687 KENTEC MEDICAL, INC.	Ameritus Transducer ATG100-U	2022-11-28
GUDID 10817522010670 KENTEC MEDICAL, INC.	Ameritus Transducer ATG100-T	2022-11-28
GUDID 10817522010663 KENTEC MEDICAL, INC.	Ameritus Transducer ATG-SLIM-T	2022-11-28
GUDID 20817522010325 KENTEC MEDICAL, INC.	Kentec ArmBoard 405ABV	2021-12-24
GUDID 20817522010318 KENTEC MEDICAL, INC.	Kentec ArmBoard 405AB	2021-12-24
GUDID 20817522010295 KENTEC MEDICAL, INC.	Kentec ArmBoard 404ABV	2021-12-24
GUDID 20817522010264 KENTEC MEDICAL, INC.	Kentec ArmBoard 403ABV	2021-12-24
GUDID 20817522010257 KENTEC MEDICAL, INC.	Kentec ArmBoard 403AB	2021-12-24
GUDID 10817522010281 KENTEC MEDICAL, INC.	Kentec ArmBoard 404AB	2021-12-24
GUDID 20817522013302 KENTEC MEDICAL, INC.	Hummi Micro-Draw ABG-HM-1	2021-06-11
GUDID 20817522013296 KENTEC MEDICAL, INC.	Ameritus Oral Syringe AEG20-KMS-BA	2020-06-11
GUDID 20817522013289 KENTEC MEDICAL, INC.	Ameritus Oral Syringe AEG10-KMS-BA	2020-06-11
GUDID 20817522013272 KENTEC MEDICAL, INC.	Ameritus Oral Syringe AEG5-KMS-BA	2020-06-11
GUDID 20817522013265 KENTEC MEDICAL, INC.	Ameritus Oral Syringe AEG3-KMS-BA	2020-06-11
GUDID 20817522013258 KENTEC MEDICAL, INC.	Ameritus Oral Syringe AEG1-KMS-BA	2020-06-11
GUDID 30817522012784 KENTEC MEDICAL, INC.	Ameritus ENFit ENF60-KMS	2020-01-22
GUDID 30817522012777 KENTEC MEDICAL, INC.	Ameritus ENFit ENF30-KMS	2020-01-22
GUDID 30817522012760 KENTEC MEDICAL, INC.	Ameritus ENFit ENF20-KMS	2020-01-22
GUDID 30817522012753 KENTEC MEDICAL, INC.	Ameritus ENFit ENF10-KMS	2020-01-22
GUDID 30817522012746 KENTEC MEDICAL, INC.	Ameritus ENFit ENF5-KMS-LD	2020-01-22
GUDID 30817522012739 KENTEC MEDICAL, INC.	Ameritus ENFit ENF3-KMS-LD	2020-01-22
GUDID 30817522012722 KENTEC MEDICAL, INC.	Ameritus ENFit ENF1-KMS-LD	2020-01-22
GUDID 30817522011541 KENTEC MEDICAL, INC.	Ameritus ENFit ENF60-KSBC	2020-01-22
GUDID 30817522011534 KENTEC MEDICAL, INC.	Ameritus ENFit ENF30-KSBC	2020-01-22
GUDID 30817522011527 KENTEC MEDICAL, INC.	Ameritus ENFit ENF20-KSBC	2020-01-22
GUDID 30817522011510 KENTEC MEDICAL, INC.	Ameritus ENFit ENF10-KSBC	2020-01-22
GUDID 30817522011503 KENTEC MEDICAL, INC.	Ameritus ENFit ENF5-KS-LDBC	2020-01-22
GUDID 30817522011497 KENTEC MEDICAL, INC.	Ameritus ENFit ENF3-KS-LDBC	2020-01-22
GUDID 30817522011480 KENTEC MEDICAL, INC.	Ameritus ENFit ENF1-KS-LDBC	2020-01-22
GUDID 30817522011473 KENTEC MEDICAL, INC.	Ameritus ENFit ENF60-KSBA	2020-01-22
GUDID 30817522011466 KENTEC MEDICAL, INC.	Ameritus ENFit ENF30-KSBA	2020-01-22
GUDID 30817522011305 KENTEC MEDICAL, INC.	Ameritus AEG60-KMS	2020-01-22
GUDID 30817522011299 KENTEC MEDICAL, INC.	Ameritus AEG5-KMS	2020-01-22
GUDID 30817522011282 KENTEC MEDICAL, INC.	Ameritus AEG3-KMS	2020-01-22
GUDID 30817522011275 KENTEC MEDICAL, INC.	Ameritus AEG30-KMS	2020-01-22
GUDID 30817522011268 KENTEC MEDICAL, INC.	Ameritus AEG20-KMS	2020-01-22
GUDID 30817522011251 KENTEC MEDICAL, INC.	Ameritus AEG1-KMS	2020-01-22
GUDID 30817522010650 KENTEC MEDICAL, INC.	Ameritus ENFit ENF20-KSBA	2020-01-22
GUDID 30817522010643 KENTEC MEDICAL, INC.	Ameritus ENFit ENF10-KSBA	2020-01-22
GUDID 30817522010636 KENTEC MEDICAL, INC.	Ameritus ENFit ENF3-KS-LDBA	2020-01-22
GUDID 30817522010629 KENTEC MEDICAL, INC.	Ameritus ENFit ENF5-KS-LDBA	2020-01-22
GUDID 30817522010612 KENTEC MEDICAL, INC.	Ameritus ENFit ENF1-KS-LDBA	2020-01-22
GUDID 30817522010001 KENTEC MEDICAL, INC.	Ameritus AEG10-KMS	2020-01-22
GUDID 30817522012821 KENTEC MEDICAL, INC.	Ameritus ENF-Straw	2019-09-23
GUDID 30817522010605 KENTEC MEDICAL, INC.	Ameritus AEG-Straw	2019-09-23
GUDID 30817522012357 KENTEC MEDICAL, INC.	Ameritus ENFit ENF-80P-80	2019-07-22
GUDID 30817522013101 KENTEC MEDICAL, INC.	Ameritus ENFit ENF-Y60P-90U	2019-07-18
GUDID 30817522012364 KENTEC MEDICAL, INC.	Ameritus ENFit ENF-Y50P-40	2019-07-18
GUDID 30817522013231 KENTEC MEDICAL, INC.	Ameritus ENFit ENFCAP-BNS	2019-07-01
PMN K162188 | PNR KENTEC MEDICAL, INC.	Ameritus ENFit(r) Enteral Syringes	2016-10-05
PMN BK960068 | KSS KENTEC MEDICAL, INC.	RadTag Gamma indicator	2014-10-22
PMN BK000008 | KSS KENTEC MEDICAL, INC.	RadTag x-ray indicator	2014-10-22
ILC KENTEC MEDICAL, INC.	Ameritus(R) Milk Straw	2013-12-31
PMN K120272 | KNT KENTEC MEDICAL, INC.	Ameritus Enteral Extension Set	2012-03-05
PMN K120272 KENTEC MEDICAL, INC.	AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET	2012-02-17
PMN K110853 | FPD KENTEC MEDICAL, INC.	Ameritus(tm) Enteral/Oral Syringe	2011-05-20
PMN K100526 | FPD KENTEC MEDICAL, INC.	Ameritus Entral(tm) Feeding Tube	2010-06-11
PMN K100526 KENTEC MEDICAL, INC.	AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE	2010-04-22
PMN K960080 | FMT KENTEC MEDICAL, INC.	AccuTemp(r) Probe	2008-04-04
PMN K050443 | DRX KENTEC MEDICAL, INC.	HAVE A HEART ELECTRODE	2006-02-07
NOC KENTEC MEDICAL, INC.	ACCU-BOARD	2006-02-07
KGX KENTEC MEDICAL, INC.	PROBE COVER	2006-02-07
KGX KENTEC MEDICAL, INC.	Accutemp(r)	2006-02-07
PMN K050443 KENTEC MEDICAL, INC.	ACCU-LEAD	2005-09-02
PMN K970686 KENTEC MEDICAL, INC.	ACCUTEMP-PROBE	1997-08-25
PMN K960080 KENTEC MEDICAL, INC.	ACCUTEMP PROBE	1996-05-01
PMN K853475 KENTEC MEDICAL, INC.	GRAM-MA NEONATAL SC	1985-09-05

Related Finance Registrations

NCAGE Code	9X556	KENTEC MEDICAL INC
NCAGE Code	65182	KENTEC MEDICAL, INC.
CAGE Code	65182	KENTEC MEDICAL, INC.
CAGE Code	9X556	KENTEC MEDICAL INC
S.A.M. Registration	65182 [66175613]	KENTEC MEDICAL, INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092947154	57037 -> Los Angeles, California	ENFIT SYRINGE	760 CTN
2020092855935	57037 -> Los Angeles, California	ENFIT SYRINGE ENTERAL FEEDING EXTENSION SET	434 CTN
2020092650514	57037 -> Los Angeles, California	ENFIT SYRINGE	760 CTN
2020092536710	57037 -> Los Angeles, California	ENFIT SYRINGE	760 CTN
2020091860796	Southhampton,United Kingdom -> Long Beach, California	NON HAZ MEDICAL SUPPLIES	45 CAS
20200914101907	Southhampton,United Kingdom -> Long Beach, California	NON HAZ MEDICAL SUPPLIES	45 CAS
202009113218	Southhampton,United Kingdom -> Los Angeles, California	SCREW CAPS WITH FOIL SEAL HS: 39235010 100ML DISPOSABLE BOTTLES IN TAMPER EVIDENT BAGS HS: 39233010 130ML STORAGE BOTTLE WITH FOIL SEAL HS: 39235010 100ML STERILE REUSABLE BOYYLES WITH FOIL SEAL HS: 39233010 TLI# USD: 3,400.00	15 PCS
2020090973832	Shanghai ,China (Mainland) -> Los Angeles, California	ENTERAL FEEDING EXTENSION SET ENFIT SYRINGE F EEDING TUBE	941 CTN
2020090973832	Shanghai ,China (Mainland) -> Los Angeles, California	ENTERAL FEEDING EXTENSION SET ENFIT SYRINGE F EEDING TUBE	941 CTN