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 Number2080225
FEI Number2080225
NameKENTEC MEDICAL, INC.
Owner & OperatorKENTEC MEDICAL, INC.
Contact Address17871 FITCH --
Irvine CA 92614 US
Official Correspondent
  • KEITH - ROOKS
  • x-800-8255996-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address17871 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
DeviceDate
KENTEC MEDICAL, INC.
 Swabeze KMI-402024-07-08
KENTEC MEDICAL, INC.
 Swabeze KMI-1112024-07-05
KENTEC MEDICAL, INC.
 Swabeze KMI-742024-07-05
KENTEC MEDICAL, INC.
 Swabeze KMI-652024-07-05
KENTEC MEDICAL, INC.
 Swabeze KMI-LA2024-06-28
KENTEC MEDICAL, INC.
 Ameritus AMG-503-SM2024-06-06
KENTEC MEDICAL, INC.
 Ameritus AMG-503-LG2024-06-06
KENTEC MEDICAL, INC.
 Kentec electrode AMG-503-PED2024-05-03
KENTEC MEDICAL, INC.
 Ameritus Transducer RATG-WAVE-U2022-11-28
KENTEC MEDICAL, INC.
 Ameritus Transducer RATG-SLIM-TB2022-11-28
KENTEC MEDICAL, INC.
 Ameritus Transducer RATG-WAVE-T2022-11-28
KENTEC MEDICAL, INC.
 Ameritus Transducer RATG-SLIM-T2022-11-28
KENTEC MEDICAL, INC.
 Ameritus Transducer RATG-AVLN-U2022-11-28
KENTEC MEDICAL, INC.
 Ameritus Transducer RATG-AVLN-T2022-11-28
KENTEC MEDICAL, INC.
 Ameritus Transducer RATG-400-U2022-11-28
KENTEC MEDICAL, INC.
 Ameritus Transducer RATG-302-T2022-11-28
KENTEC MEDICAL, INC.
 Ameritus Transducer RATG-200-U2022-11-28
KENTEC MEDICAL, INC.
 Ameritus Transducer RATG-200-T2022-11-28
KENTEC MEDICAL, INC.
 Ameritus Transducer RATG-100-U2022-11-28
KENTEC MEDICAL, INC.
 Ameritus Transducer RATG-100-T2022-11-28
KENTEC MEDICAL, INC.
 Ameritus Transducer ATG-WAVE-UB2022-11-28
KENTEC MEDICAL, INC.
 Ameritus Transducer ATG-WAVE-U2022-11-28
KENTEC MEDICAL, INC.
 Ameritus Transducer ATG-WAVE-TB2022-11-28
KENTEC MEDICAL, INC.
 Ameritus Transducer ATG-WAVE-T2022-11-28
KENTEC MEDICAL, INC.
 Ameritus Transducer ATG-SLIM-TB2022-11-28
KENTEC MEDICAL, INC.
 Ameritus Transducer ATG402-TB2022-11-28
KENTEC MEDICAL, INC.
 Ameritus Transducer ATG402-T2022-11-28
KENTEC MEDICAL, INC.
 Ameritus Transducer ATG400-UB2022-11-28
KENTEC MEDICAL, INC.
 Ameritus Transducer ATG400-U2022-11-28
KENTEC MEDICAL, INC.
 Ameritus Transducer ATG303-TB2022-11-28
KENTEC MEDICAL, INC.
 Ameritus Transducer ATG300-U2022-11-28
KENTEC MEDICAL, INC.
 Ameritus Transducer ATG200-U2022-11-28
KENTEC MEDICAL, INC.
 Ameritus Transducer ATG200-T2022-11-28
KENTEC MEDICAL, INC.
 Ameritus Transducer ATG100-U2022-11-28
KENTEC MEDICAL, INC.
 Ameritus Transducer ATG100-T2022-11-28
KENTEC MEDICAL, INC.
 Ameritus Transducer ATG-SLIM-T2022-11-28
KENTEC MEDICAL, INC.
 Kentec ArmBoard 405ABV2021-12-24
KENTEC MEDICAL, INC.
 Kentec ArmBoard 405AB2021-12-24
KENTEC MEDICAL, INC.
 Kentec ArmBoard 404ABV2021-12-24
KENTEC MEDICAL, INC.
 Kentec ArmBoard 403ABV2021-12-24
KENTEC MEDICAL, INC.
 Kentec ArmBoard 403AB2021-12-24
KENTEC MEDICAL, INC.
 Kentec ArmBoard 404AB2021-12-24
KENTEC MEDICAL, INC.
 Hummi Micro-Draw ABG-HM-12021-06-11
KENTEC MEDICAL, INC.
 Ameritus Oral Syringe AEG20-KMS-BA2020-06-11
KENTEC MEDICAL, INC.
 Ameritus Oral Syringe AEG10-KMS-BA2020-06-11
KENTEC MEDICAL, INC.
 Ameritus Oral Syringe AEG5-KMS-BA2020-06-11
KENTEC MEDICAL, INC.
 Ameritus Oral Syringe AEG3-KMS-BA2020-06-11
KENTEC MEDICAL, INC.
 Ameritus Oral Syringe AEG1-KMS-BA2020-06-11
KENTEC MEDICAL, INC.
 Ameritus ENFit ENF60-KMS2020-01-22
KENTEC MEDICAL, INC.
 Ameritus ENFit ENF30-KMS2020-01-22
KENTEC MEDICAL, INC.
 Ameritus ENFit ENF20-KMS2020-01-22
KENTEC MEDICAL, INC.
 Ameritus ENFit ENF10-KMS2020-01-22
KENTEC MEDICAL, INC.
 Ameritus ENFit ENF5-KMS-LD2020-01-22
KENTEC MEDICAL, INC.
 Ameritus ENFit ENF3-KMS-LD2020-01-22
KENTEC MEDICAL, INC.
 Ameritus ENFit ENF1-KMS-LD2020-01-22
KENTEC MEDICAL, INC.
 Ameritus ENFit ENF60-KSBC2020-01-22
KENTEC MEDICAL, INC.
 Ameritus ENFit ENF30-KSBC2020-01-22
KENTEC MEDICAL, INC.
 Ameritus ENFit ENF20-KSBC2020-01-22
KENTEC MEDICAL, INC.
 Ameritus ENFit ENF10-KSBC2020-01-22
KENTEC MEDICAL, INC.
 Ameritus ENFit ENF5-KS-LDBC2020-01-22
KENTEC MEDICAL, INC.
 Ameritus ENFit ENF3-KS-LDBC2020-01-22
KENTEC MEDICAL, INC.
 Ameritus ENFit ENF1-KS-LDBC2020-01-22
KENTEC MEDICAL, INC.
 Ameritus ENFit ENF60-KSBA2020-01-22
KENTEC MEDICAL, INC.
 Ameritus ENFit ENF30-KSBA2020-01-22
KENTEC MEDICAL, INC.
 Ameritus AEG60-KMS2020-01-22
KENTEC MEDICAL, INC.
 Ameritus AEG5-KMS2020-01-22
KENTEC MEDICAL, INC.
 Ameritus AEG3-KMS2020-01-22
KENTEC MEDICAL, INC.
 Ameritus AEG30-KMS2020-01-22
KENTEC MEDICAL, INC.
 Ameritus AEG20-KMS2020-01-22
KENTEC MEDICAL, INC.
 Ameritus AEG1-KMS2020-01-22
KENTEC MEDICAL, INC.
 Ameritus ENFit ENF20-KSBA2020-01-22
KENTEC MEDICAL, INC.
 Ameritus ENFit ENF10-KSBA2020-01-22
KENTEC MEDICAL, INC.
 Ameritus ENFit ENF3-KS-LDBA2020-01-22
KENTEC MEDICAL, INC.
 Ameritus ENFit ENF5-KS-LDBA2020-01-22
KENTEC MEDICAL, INC.
 Ameritus ENFit ENF1-KS-LDBA2020-01-22
KENTEC MEDICAL, INC.
 Ameritus AEG10-KMS2020-01-22
KENTEC MEDICAL, INC.
 Ameritus ENF-Straw2019-09-23
KENTEC MEDICAL, INC.
 Ameritus AEG-Straw2019-09-23
KENTEC MEDICAL, INC.
 Ameritus ENFit ENF-80P-802019-07-22
KENTEC MEDICAL, INC.
 Ameritus ENFit ENF-Y60P-90U2019-07-18
KENTEC MEDICAL, INC.
 Ameritus ENFit ENF-Y50P-402019-07-18
KENTEC MEDICAL, INC.
 Ameritus ENFit ENFCAP-BNS2019-07-01
KENTEC MEDICAL, INC.
Ameritus ENFit(r) Enteral Syringes2016-10-05
KENTEC MEDICAL, INC.
RadTag Gamma indicator2014-10-22
KENTEC MEDICAL, INC.
RadTag x-ray indicator2014-10-22
KENTEC MEDICAL, INC.
Ameritus(R) Milk Straw2013-12-31
KENTEC MEDICAL, INC.
Ameritus Enteral Extension Set2012-03-05
KENTEC MEDICAL, INC.
AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET2012-02-17
KENTEC MEDICAL, INC.
Ameritus(tm) Enteral/Oral Syringe2011-05-20
KENTEC MEDICAL, INC.
Ameritus Entral(tm) Feeding Tube2010-06-11
KENTEC MEDICAL, INC.
AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE2010-04-22
KENTEC MEDICAL, INC.
AccuTemp(r) Probe2008-04-04
KENTEC MEDICAL, INC.
HAVE A HEART ELECTRODE2006-02-07
KENTEC MEDICAL, INC.
ACCU-BOARD2006-02-07
KENTEC MEDICAL, INC.
PROBE COVER2006-02-07
KENTEC MEDICAL, INC.
Accutemp(r)2006-02-07
KENTEC MEDICAL, INC.
ACCU-LEAD2005-09-02
KENTEC MEDICAL, INC.
ACCUTEMP-PROBE1997-08-25
KENTEC MEDICAL, INC.
ACCUTEMP PROBE1996-05-01
KENTEC MEDICAL, INC.
GRAM-MA NEONATAL SC1985-09-05

Related Finance Registrations
NCAGE Code9X556KENTEC MEDICAL INC
NCAGE Code65182KENTEC MEDICAL, INC.
CAGE Code65182KENTEC MEDICAL, INC.
CAGE Code9X556KENTEC MEDICAL INC
S.A.M. Registration65182 [66175613]KENTEC MEDICAL, INC.
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
202009294715457037 -> Los Angeles, CaliforniaENFIT SYRINGE760 CTN
202009285593557037 -> Los Angeles, CaliforniaENFIT SYRINGE ENTERAL FEEDING EXTENSION SET434 CTN
202009265051457037 -> Los Angeles, CaliforniaENFIT SYRINGE760 CTN
202009253671057037 -> Los Angeles, CaliforniaENFIT SYRINGE760 CTN
2020091860796Southhampton,United Kingdom -> Long Beach, CaliforniaNON HAZ MEDICAL SUPPLIES45 CAS
20200914101907Southhampton,United Kingdom -> Long Beach, CaliforniaNON HAZ MEDICAL SUPPLIES45 CAS
202009113218Southhampton,United Kingdom -> Los Angeles, CaliforniaSCREW 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: 3,400.0015 PCS
2020090973832Shanghai ,China (Mainland) -> Los Angeles, CaliforniaENTERAL FEEDING EXTENSION SET ENFIT SYRINGE F EEDING TUBE941 CTN
2020090973832Shanghai ,China (Mainland) -> Los Angeles, CaliforniaENTERAL FEEDING EXTENSION SET ENFIT SYRINGE F EEDING TUBE941 CTN
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