121 results
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18ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), sterile, latex free. R-Med Re-Order # 55170R; Distributed by R-Med, Inc., Orgeon, OH
FDA Recall
Terminated
·Vital Concepts, Inc.·Product code GCY·July 11, 2003
CT Goldseal BrightSpeed 16 PWR TIO 2 YR
FDA Recall
Terminated
·GE Healthcare, LLC·Product code JAK·May 24, 2018
CT Goldseal BrightSpeed 16 PWR TIO 2 YR
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·August 8, 2018
COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM II Software
FDA Enforcement
Class I
·Terminated·Beckman Coulter Inc.·November 28, 2018
Coloplast, Saline Filled Testicular Prosthesis, Sterile R, Manufacturer Coloplast A/S 3050 Denmark. Catalogue Number Description Part Number 450-1323 Extra Small 520600 450-1325 Small 520610 450-1327 Medium 520630 450-1329 Large 520650 The Coloplast Saline-Filled Testicular Prosthesis is intended for use when cosmetic testicular replacement is indicated i.e., in the case of agenesis or following the surgical removal of a testicle. The Butterfly Needle is used to fill the implant with saline.
FDA Recall
Terminated
·Coloplast Manufacturing US, LLC·Product code FAF·April 30, 2010
Novaplus Sheridan/HVT Cuffed, Murphy Eye Tracheal Tube; an Rx, ETO sterilized, single use device inserted into the patient's trachea via the mouth to maintain an open airway; Hudson RCI, Temecula, CA 92589-9020, Manufactured in Mexico, Catalog number (REF) V5-10316 (8.0 mm)
FDA Recall
Terminated
·Teleflex Medical·Product code BTR·January 14, 2005
Mallinckrodt Satin-Slip Intubation Stylet, 6 Fr., single use, Model number 85863,shipped in cases of 20
FDA Recall
Terminated
·Nellcor Puritan Bennett·Product code BSR·July 12, 2006
Portex Tracheal Tube, Oral/Nasal, Murphy Eye, Siliconized, 2.5 mm Product Code: 100/141/025. Intended for oral and/or nasal intubation for airway management.
FDA Recall
Terminated
·Smiths Medical Hythe Hythe, Kent United Kingdom·Product code BTR·August 25, 2009
Portex Tracheal Tube, Oral/Nasal, Murphy Eye, Siliconized, 3.5 mm Product Code: 100/141/035. Intended for oral and/or nasal intubation for airway management.
FDA Recall
Terminated
·Smiths Medical Hythe Hythe, Kent United Kingdom·Product code BTR·August 25, 2009
Vital Signs Intubation Pack, Part Number: INTPKF, Sterile, Vital Signs Colorado Inc, Englewood, CO 80112. Contains one lighted stylet per pack.
FDA Recall
Terminated
·Vital Signs Colorado Inc.·Product code BSR·August 11, 2008
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
FDA Recall
Terminated
·Teleflex Medical·Product code BTR·January 6, 2014
Rsch Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip, Sterile, Rx only, Teleflex Medical.
FDA Recall
Terminated
·Teleflex Medical·Product code BSR·August 24, 2015
Sheridan/CF Novaplus 7.0 mm, Product Code V5-10114 Product Usage: Tracheal tube/airway management
FDA Recall
Terminated
·Teleflex Medical·Product code BTR·May 24, 2019
Hudson RCI Sheridan: 1) HVT 6.0 mm, Product Code 5-10312 2) HVT 6.5 mm, Product Code 5-10313 3) HVT 7.0 mm, Product Code 5-10314 4) HVT 7.5 mm, Product Code 5-10315 5) HVT 8.0 mm, Product Code 5-10316 6) HVT 8.5 mm, Product Code 5-10317 Product Usage: Tracheal tube/airway management
FDA Recall
Terminated
·Teleflex Medical·Product code BTR·May 24, 2019
Portex Polar Preformed Tracheal Tube, South Oral, Murphy Eye, Clear 3.5 mm Product Code: 100/134/035. Intended for oral and/or nasal intubation for airway management.
FDA Recall
Terminated
·Smiths Medical Hythe Hythe, Kent United Kingdom·Product code BTR·August 25, 2009
Portex Tracheal Tube, Cut to Length, Oral, Siliconized, 2.5 mm Product Code: 100/126/025. Intended for oral and/or nasal intubation for airway management.
FDA Recall
Terminated
·Smiths Medical Hythe Hythe, Kent United Kingdom·Product code BTR·August 25, 2009
Portex Uncuffed Paediatric Sized Tracheal Tube Oral Nasal, Ivory 3.0 mm, Product Code: 100/105/030. Intended for oral and/or nasal intubation for airway management.
FDA Recall
Terminated
·Smiths Medical Hythe Hythe, Kent United Kingdom·Product code BTR·August 25, 2009
Portex Tracheal Tube, Oral/Nasal, Murphy Eye, Clear, 3.0 mm Product Code: 100/127/030. Intended for oral and/or nasal intubation for airway management.
FDA Recall
Terminated
·Smiths Medical Hythe Hythe, Kent United Kingdom·Product code BTR·August 25, 2009
Kimberly Clark Microcuff Endotracheal Tube, Pediatric Oral Curved, sizes 3.0mm, 3.5mm, 4.0mm and 4.5mm, Rx Only, Sterile, Manufacturer: Kimberly-Clark NV Belgicastraat 13, 1930 Zaventem, Belgium, Made in Malaysia
FDA Recall
Terminated
·Kimberly-Clark Corporation·Product code BTR·June 4, 2007
Light Wand Intro Pack, Part Number: 3960, Sterile, Vital Signs Colorado, Inc., Englewood, CO. Contains 5 lighted stylets per pack.
FDA Recall
Terminated
·Vital Signs Colorado Inc.·Product code BSR·August 11, 2008