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KENTEC MEDICAL, INC.

Last updated September 17, 2026

Information

Country: US
Address: 17871 FITCH, Irvine, CA, 92614
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 2080225
DUNS Number: —

Catalogue (243)

Page 5 of 5

Device	Model / Reference	Registries	Class	Status
Ameritus ENFit	ENF-Y80P-50	FDA UDI	Class II	Active
Ameritus Transducer	ATG402-TB	FDA UDI	Class II	Active
Ameritus ENFit	ENF-Y100P-90	FDA UDI	Class II	Active
Ameritus	AEG-40P-50	FDA UDI	Class II	Active
Ameritus	AEG-40P-80	FDA UDI	Class II	Active
Ameritus ENFit	ENF-Y50P-80	FDA UDI	Class II	Active
Ameritus ENFit	ENF-EXT-060	FDA UDI	Class II	Active
Ameritus ENFit	ENF10-KSBC	FDA UDI	Class II	Active
Ameritus ENFit	ENF-Y60P-90U	FDA UDI	Class II	Active
Kentec ArmBoard	404AB	FDA UDI	Class I	Active
Ameritus ENFit	ENF60-KSBA	FDA UDI	Class II	Active
Ameritus ENFit	ENF-80P-50U	FDA UDI	Class II	Active
Ameritus Transducer	RATG-200-T	FDA UDI	Class II	Active
Ameritus ENFit	ENF-60P-80	FDA UDI	Class II	Active
Ameritus ENFit	ENF-Y50P-50	FDA UDI	Class II	Active
Ameritus ENFit	ENF60-KSBC	FDA UDI	Class II	Active
Kentec electrode	AMG-503-PED	FDA UDI	Class II	Active
Ameritus ENFit	ENF-60P-90	FDA UDI	Class II	Active
Ameritus ENFit	ENF30-KMS	FDA UDI	Class II	Active
Ameritus ENFit	ENF-Y80P-40	FDA UDI	Class II	Active
Disposable 22mm. Flexible Adaptor	K810621	FDA 510(k)	Class I	Active
Giant Lumen Safetip Series: Endomyocardial Biopsy	K903840	FDA 510(k)	Class II	Active
The Guider Coronary Guiding Catheter	K903216	FDA 510(k)	Class II	Active
Disposable Elbow Adaptor	K810620	FDA 510(k)	Class I	Active
Disp. Hyperinflation Bag System	K813317	FDA 510(k)	Class II	Active
Interflo Medical Model F-1 Thermodilution Catheter	K900710	FDA 510(k)	Class II	Active
Interflo Medical Model Pa3-H Cco/Pac Catheter	K911840	FDA 510(k)	Class II	Active
Disposable Adult Vo. Ventilator Circuit	K823271	FDA 510(k)	Class I	Active
Tri Adapter W/Adjustable Hemostasis Valves	K901247	FDA 510(k)	Class II	Active
Amcath Ureteral Dilators Models 7100, 7110, 7120	K894925	FDA 510(k)	Class II	Active
Accutemp Probe	K960080	FDA 510(k)	Class II	Active
Percutaneous Catheter Introducer Kit	K903906	FDA 510(k)	Class II	Active
Disposable Pressure Line Adaptor	K801260	FDA 510(k)	Class I	Active
Interventional Medical Y Adapter W/Adjust. Valve	K900998	FDA 510(k)	Class II	Active
Ameritus Entral (tm) Enteral Feeding Tube	K100526	FDA 510(k)	Class II	Active
Disposable Hand Held Nebulizer	K800562	FDA 510(k)	Class II	Active
Tapered Tip The Guider Coronary Guiding Catheter	K903217	FDA 510(k)	Class II	Active
Accutemp-Probe	K970686	FDA 510(k)	Class II	Active
Gram-Ma Neonatal Sc	K853475	FDA 510(k)	Class I	Active
Ameritus Medical Enteral Feeding Extension Set	K120272	FDA 510(k)	Class II	Active
Disposable Heated Wire Loops 48 And 72	K860941	FDA 510(k)	Class II	Active
Accu-Lead	K050443	FDA 510(k)	Class II	Active
Disposable Coupling Adaptor	K801261	FDA 510(k)	Class I	Active

Related Companies

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FDA Recalls (10)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jan 17, 2020	Z-2514-2020	—	terminated	Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube is placed into patient (2) Patient could be unnecessarily overexposed to radiation if multiple x-rays are needed to confirm placement of a new tube, if x-ray is used as the placement confirmation method.
Jan 17, 2020	Z-2517-2020	—	terminated	Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube is placed into patient (2) Patient could be unnecessarily overexposed to radiation if multiple x-rays are needed to confirm placement of a new tube, if x-ray is used as the placement confirmation method.
Jan 17, 2020	Z-2516-2020	—	terminated	Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube is placed into patient (2) Patient could be unnecessarily overexposed to radiation if multiple x-rays are needed to confirm placement of a new tube, if x-ray is used as the placement confirmation method.
Jan 17, 2020	Z-2518-2020	—	terminated	Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube is placed into patient (2) Patient could be unnecessarily overexposed to radiation if multiple x-rays are needed to confirm placement of a new tube, if x-ray is used as the placement confirmation method.
Jan 17, 2020	Z-2519-2020	—	terminated	Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube is placed into patient (2) Patient could be unnecessarily overexposed to radiation if multiple x-rays are needed to confirm placement of a new tube, if x-ray is used as the placement confirmation method.
Jan 17, 2020	Z-2520-2020	—	terminated	Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube is placed into patient (2) Patient could be unnecessarily overexposed to radiation if multiple x-rays are needed to confirm placement of a new tube, if x-ray is used as the placement confirmation method.
Jan 17, 2020	Z-2515-2020	—	terminated	Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube is placed into patient (2) Patient could be unnecessarily overexposed to radiation if multiple x-rays are needed to confirm placement of a new tube, if x-ray is used as the placement confirmation method.
Jun 23, 2017	Z-3073-2017	—	terminated	Inadequate detectability of radiopaque stripes
Jun 23, 2017	Z-3074-2017	—	terminated	Inadequate detectability of radiopaque stripes
May 18, 2007	Z-1188-2008	—	terminated	Incompatible components: The Finger Clip Sensors - with a Serial Number prefix of PA514, PA515, YE508, ZC502 and ZG512 - are missing an additional diode and higher resistor in its existing configuration making them inoperable when used to interface with those Ohmeda Tuffsat monitors previously re-configured by Ohmeda to include a detection circuit for diodes.