279 results
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48ms
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Sources: EU EUDAMED, US FDA
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-50P-50 (5 fr. 50 cm ENFit Enteral Feeding Tube).
FDA Enforcement
Class II
·Terminated·Kentec Medical, Inc·July 15, 2020
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-Y60P-80 (6 fr. 80 cm ENFit Enteral Feeding Tube with Y-Port).
FDA Enforcement
Class II
·Terminated·Kentec Medical, Inc·July 15, 2020
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-Y60P-50 (6 fr. 50 cm ENFit Enteral Feeding Tube with Y-Port).
FDA Enforcement
Class II
·Terminated·Kentec Medical, Inc·July 15, 2020
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-40P-50 (4 fr. 50 cm ENFit Enteral Feeding Tube).
FDA Enforcement
Class II
·Terminated·Kentec Medical, Inc·July 15, 2020
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-80P-50 (8 fr. 50 cm ENFit Enteral Feeding Tube).
FDA Enforcement
Class II
·Terminated·Kentec Medical, Inc·July 15, 2020
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-60P-50 (6 fr. 50 cm ENFit Enteral Feeding Tube).
FDA Enforcement
Class II
·Terminated·Kentec Medical, Inc·July 15, 2020
POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, REF Numbers: a) ENF-50P-40 b) ENF-50P-50 c) ENF-50P-80 d) ENF-60P-40 e) ENF-60P-50 f) ENF-60P-80 g) ENF-80P-40 h) ENF-80P-50 i) ENF-80P-80 j) ENF-100P-110 For pediatric and Neonatal Use, ENFit ENTERAL USE ONLY, RADIOPAQUE STRIPE, STERILE, EO, SINGLE USE ONLY, QTY 10/BOX.
FDA Enforcement
Class II
·Terminated·Kentec Medical Inc·September 6, 2017
POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, WITH SIDE PORT, REF Numbers: a) ENF-Y50P-40 b) ENF-Y50P-50 c) ENF-Y60P-40 d) ENF-Y60P-50 e) ENF-Y60P-90 f) ENF-Y80P-40 g) ENF-Y80P-50 h) ENF-Y80P-80 i) ENF-Y80P-90 For pediatric and Neonatal Use, ENFit ENTERAL USE ONLY, RADIOPAQUE STRIPE, STERILE, EO, SINGLE USE ONLY, QTY 10/BOX.
FDA Enforcement
Class II
·Terminated·Kentec Medical Inc·September 6, 2017
SILICONE BILIARY CATHETER
FDA Adverse Event
Malfunction
·BENTEC MEDICAL, INC.·Product code FGE·November 18, 2016
ACCUTEMP PLUS
FDA Adverse Event
Malfunction
·KEWTEC MEDICAL, INC.·Product code FMT·July 15, 1999
Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
FDA Recall
Open, Classified
·Percussionaire Corporation·Product code BZO·August 21, 2024
Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
FDA Recall
Open, Classified
·Percussionaire Corporation·Product code BZO·August 21, 2024
VIVISOL Nederland B.V.
Importer
🇳🇱 Netherlands·4 Manufacturers
Cardiotec Medical Ltd
Importer
🇮🇪 Ireland·6 Manufacturers
MedNet EC-REP C IIb GmbH
Authorized representative
🇩🇪 Germany·36 Manufacturers·989 Devices
Oxigen Salud, S.A.
Importer
🇪🇸 Spain·17 Manufacturers
PROYECTOS HOSPITALARIOS INTERNACIONAL, S.A
Importer
🇪🇸 Spain·23 Manufacturers
MedNet EC-REP GmbH
Authorized representative
🇩🇪 Germany·464 Manufacturers·5263 Devices
Wolfram Droh GmbH
Importer
🇩🇪 Germany·20 Manufacturers