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Sign in to claim this brandKENTEC MEDICAL, INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 17871 FITCH, Irvine, CA, 92614
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 2080225
- DUNS Number
- —
Catalogue (243)
Page 1 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ameritus Transducer | ATG-SLIM-T | FDA UDI | Class II | Active |
| Ameritus ENFit | ENF-80P-40 | FDA UDI | Class II | Active |
| Ameritus | AEG-40S-50 | FDA UDI | Class II | Active |
| Ameritus Transducer | RATG-WAVE-T | FDA UDI | Class II | Active |
| Ameritus | AEG-Y60P-90 | FDA UDI | Class II | Active |
| Ameritus | AEG-60P-80 | FDA UDI | Class II | Active |
| Ameritus Transducer | ATG-WAVE-TB | FDA UDI | Class II | Active |
| Ameritus Transducer | RATG-SLIM-T | FDA UDI | Class II | Active |
| IV extension set | KMI436 | FDA UDI | Class II | Active |
| Ameritus | AEG60-KMS | FDA UDI | Class II | Active |
| Ameritus | AEG-120P-80 | FDA UDI | Class II | Active |
| Ameritus | AEG-60S-40 | FDA UDI | Class II | Active |
| Ameritus | AEG-80P-80 | FDA UDI | Class II | Active |
| Ameritus | AEG-60P-80 | FDA UDI | Class II | Active |
| Ameritus | AEG-Y1SC-060 | FDA UDI | Class II | Active |
| Ameritus | AEG-Y50P-90 | FDA UDI | Class II | Active |
| Ameritus | AEG-Straw | FDA UDI | Class I | Active |
| Ameritus ENFit | ENF5-KS-LDBC | FDA UDI | Class II | Active |
| Ameritus ENFit | ENFCAP-BNS | FDA UDI | Class II | Active |
| Ameritus | AEG-80P-90 | FDA UDI | Class II | Active |
| Kentec ArmBoard | 403ABV | FDA UDI | Class I | Active |
| Swabeze | KMI-74 | FDA UDI | Class I | Active |
| Ameritus | AEG-Y80P-90 | FDA UDI | Class II | Active |
| Ameritus ENFit | ENF-100P-110 | FDA UDI | Class II | Active |
| Ameritus ENFit | ENF5-KMS-LD | FDA UDI | Class II | Active |
| Ameritus ENFit | ENF20-KMS | FDA UDI | Class II | Active |
| Ameritus | AEG-Y50P-50 | FDA UDI | Class II | Active |
| Ameritus | AEG-80P-40 | FDA UDI | Class II | Active |
| IV extension set | KMI636 | FDA UDI | Class II | Active |
| Ameritus | AEG-Y80P-50 | FDA UDI | Class II | Active |
| Ameritus | AEG-50P-50 | FDA UDI | Class II | Active |
| Ameritus ENFit | ENF-Y60P-40 | FDA UDI | Class II | Active |
| Swabeze | KMI-111 | FDA UDI | Class I | Active |
| Ameritus ENFit | ENF-Y60P-50 | FDA UDI | Class II | Active |
| Ameritus ENFit | ENF30-KSBA | FDA UDI | Class II | Active |
| Ameritus ENFit | ENF20-KSBC | FDA UDI | Class II | Active |
| Ameritus | AEG-Y80P-110 | FDA UDI | Class II | Active |
| Ameritus | AEG-40P-90 | FDA UDI | Class II | Active |
| Ameritus | AEG-Y60P-50 | FDA UDI | Class II | Active |
| Ameritus ENFit | ENF-Y80P-90 | FDA UDI | Class II | Active |
| Ameritus ENFit | ENF-60P-50 | FDA UDI | Class II | Active |
| Ameritus | AEG-Y60P-80 | FDA UDI | Class II | Active |
| Ameritus | AEG-60P-90 | FDA UDI | Class II | Active |
| Ameritus | AEG-120P-110 | FDA UDI | Class II | Active |
| Ameritus | AEG-40P-80 | FDA UDI | Class II | Active |
| Ameritus | AEG-60S-50 | FDA UDI | Class II | Active |
| Ameritus Transducer | ATG-WAVE-U | FDA UDI | Class II | Active |
| Ameritus | AEG5-KMS | FDA UDI | Class II | Active |
| Ameritus ENFit | ENF-80P-50 | FDA UDI | Class II | Active |
| Ameritus | AEG-Y80P-80 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
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. |