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KENTEC MEDICAL, INC.

Last updated September 17, 2026

Information

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

Catalogue (243)

Page 4 of 5

Device	Model / Reference	Registries	Class	Status
Ameritus	AEG-40P-90	FDA UDI	Class II	Active
Ameritus Transducer	RATG-SLIM-TB	FDA UDI	Class II	Active
Ameritus ENFit	ENF-40P-90	FDA UDI	Class II	Active
Ameritus	AEG-Y80P-110	FDA UDI	Class II	Active
Ameritus Transducer	ATG-WAVE-T	FDA UDI	Class II	Active
Ameritus ENFit	ENF-40P-50	FDA UDI	Class II	Active
Ameritus	AEG-Y50P-80	FDA UDI	Class II	Active
Kentec ArmBoard	404ABV	FDA UDI	Class I	Active
Ameritus	AEG-100P-80	FDA UDI	Class II	Active
Ameritus Oral Syringe	AEG1-KMS-BA	FDA UDI	Class I	Active
Ameritus	OC-ENT-036	FDA UDI	Class II	Active
Ameritus	AMG-503-SM	FDA UDI	Class II	Active
Ameritus Transducer	RATG-AVLN-T	FDA UDI	Class II	Active
Ameritus	AEG-1SC-036	FDA UDI	Class II	Active
Ameritus	AEG-Y80P-40	FDA UDI	Class II	Active
Ameritus ENFit	ENF3-KS-LDBA	FDA UDI	Class II	Active
Ameritus	AEGCAP-BNS	FDA UDI	Class II	Active
Ameritus	AEG-Y80P-80	FDA UDI	Class II	Active
Ameritus	AEG-80S-80	FDA UDI	Class II	Active
Swabeze	KMI-40	FDA UDI	Class I	Active
Ameritus Transducer	ATG100-U	FDA UDI	Class II	Active
Ameritus	AEG-40S-80	FDA UDI	Class II	Active
Ameritus	AEG-Y60P-80	FDA UDI	Class II	Active
Ameritus Transducer	ATG200-T	FDA UDI	Class II	Unknown
Ameritus Transducer	ATG402-T	FDA UDI	Class II	Active
Ameritus	YOC-ENT-060	FDA UDI	Class II	Active
Ameritus ENFit	ENF-50P-90	FDA UDI	Class II	Active
Ameritus	175	FDA UDI	Class I	Active
Ameritus Transducer	ATG400-UB	FDA UDI	Class II	Active
Ameritus	AEG-Y80P-90	FDA UDI	Class II	Active
Ameritus Transducer	ATG400-U	FDA UDI	Class II	Active
Ameritus	AEG-Y60P-40	FDA UDI	Class II	Active
Ameritus	AEG10-KMS	FDA UDI	Class II	Active
Ameritus	OC-ENT-022	FDA UDI	Class II	Active
IV extension set	KMI467C	FDA UDI	Class II	Active
Ameritus ENFit	ENF-Y50P-40	FDA UDI	Class II	Active
Ameritus	AEG-Y100P-110	FDA UDI	Class II	Active
Ameritus	AEG-80P-50	FDA UDI	Class II	Active
Ameritus	175-s	FDA UDI	Class I	Active
Ameritus ENFit	ENF-60P-110	FDA UDI	Class II	Active
Ameritus	120	FDA UDI	Class I	Active
Ameritus	232	FDA UDI	Class II	Active
AccuTemp Probe	230H	FDA UDI	Class II	Active
Ameritus Transducer	RATG-400-U	FDA UDI	Class II	Active
Ameritus ENFit	ENF3-KMS-LD	FDA UDI	Class II	Active
Ameritus ENFit	ENF-Y50P-90	FDA UDI	Class II	Active
Ameritus ENFit	ENF-50P-50	FDA UDI	Class II	Active
Ameritus Transducer	ATG-SLIM-TB	FDA UDI	Class II	Active
Ameritus ENFit	ENF-Y60P-80	FDA UDI	Class II	Active
Ameritus Transducer	RATG-WAVE-U	FDA UDI	Class II	Active

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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.