37 results
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20ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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regard SHOULDER W BCH CHAIR, OR00356F, Item Number 800203006; ortho surgery convenience kit
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 30, 2022
regard SHOULDER W BCH CHAIR, OR00356F, Item Number 800203006; ortho surgery convenience kit
FDA Recall
Terminated
·ROi CPS LLC·Product code OJH·October 20, 2022
Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end of the endoscopes through the instrument channel. Compatible endoscopes include Olympus bronchoscopes, cystoscopes, rhino-laryngoscopes and pleurascopes models.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·August 14, 2019
CONSERVE, TOTAL A-CLASS HEAD W/BFH TECH., REF 38AM-3635, O.D. Size: 36mm, Neck Length: +3.5mm, Taper: SLT, Sterile R, 1 each, Rx only, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002. The CONSERVE Total Femoral Head is indicated for use in total hip arthroplasty for reduction of relief of pain and/or improved hip function in skeletally mature patients.
FDA Recall
Terminated
·Wright Medical Technology Inc·Product code JDL·May 14, 2009
CONSERVE, TOTAL A-CLASS HEAD W/BFH TECH., REF 38AM-3604, O.D. Size: 36mm, Neck Length: -3.5mm, Taper: SLT, Sterile R, 1 each, Rx only, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002. The CONSERVE Total Femoral Head is indicated for use in total hip arthroplasty for reduction of relief of pain and/or improved hip function in skeletally mature patients.
FDA Recall
Terminated
·Wright Medical Technology Inc·Product code JDL·May 14, 2009
Disposable Water Trap with ''T'' for Ventilator Circuits; product reorder 6090; SIngle Patient Use only; IPI label - Manufactured by IPI Medical Products, 3217 N. Kilpatrick St., Chicago, IL 60641and Medex label - Manufactured by Medex, Carlsbad, CA 92008
FDA Recall
Terminated
·Medex Inc·Product code BYH·July 12, 2004
Hospitak, REF 962-E, Adapter 22mm/15mm, manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico
FDA Recall
Terminated
·Unomedical, Inc·Product code BZA·December 2, 2004
Hudson RICA Sheridan, EB Tube, Sher-I-Bronch, LS, 35FR, Nova Plus, 37FR, 39 FR, and 41 FR, Teleflex Medical, Research Triangle Park, NC 27709. Indicated for use in thoracic surgery, bronchospirometry, for the administration of endobronchial anesthesia and other uses commonly associated with endobronchial tubes.
FDA Recall
Terminated
·Teleflex Medical·Product code BZA·July 31, 2009
Hudson RICA Sher-I-Swiv & Sher-I-Swiv F/O, Teleflex Medical, Research Triangle Park, NC 27709. Indicated for use in thoracic surgery, bronchospirometry, for the administration of endobronchial anesthesia and other uses commonly associated with endobronchial tubes.
FDA Recall
Terminated
·Teleflex Medical·Product code BZA·July 31, 2009
Disposable Water Trap with ''Y'' for Ventilator Circuits; product reorder 6091; SIngle Patient Use only; IPI label - Manufactured by IPI Medical Products, 3217 N. Kilpatrick St., Chicago, IL 60641and Medex label - Manufactured by Medex, Carlsbad, CA 92008
FDA Recall
Terminated
·Medex Inc·Product code BYH·July 12, 2004
Hospitak, REF CD1N4Y-E, Mapleson D. Anesthesia Non-Rebreathing Circuit, 10'', manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico
FDA Recall
Terminated
·Unomedical, Inc·Product code BZA·December 2, 2004
Viasys, REF BLD-14660, Pulmanex Adult Transport Circuit w/ Exhalation Valve, Non-Heated, 60'', manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico
FDA Recall
Terminated
·Unomedical, Inc·Product code BZA·December 2, 2004
Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644, QTY 50 Product Usage: for use in respiratory and anesthesia circuits to connect two or more components of a breathing system.
FDA Recall
Terminated
·Teleflex Medical Europe Ltd Ida Business Park Athlone Ireland·Product code BZA·March 27, 2018
Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3503031. Airway connector.
FDA Recall
Terminated
·Intersurgical Inc·Product code BZA·August 7, 2019
Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use Only, Date of Manufacture XXXX, Expiration Date XXXX, LF, UDI: (01) 00630094916019 - Product Usage: Airway connectors intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or mask.
FDA Recall
Terminated
·Bioseal Corporation·Product code BZA·August 15, 2019
Hospitak, REF 1450, Face Ten Mask w/ Aerosol Tubing 60'', Oxygen Tubing 7'' & Connector, manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico
FDA Recall
Terminated
·Unomedical, Inc·Product code BZA·December 2, 2004
Hospitak, REF 903-E, IPPB Ventilator Circuit, manufactured by Unomedical, Inc of McAllen , Texas and assembled in Mexico
FDA Recall
Terminated
·Unomedical, Inc·Product code BZA·December 2, 2004
Viasys, REF BLD-1000, Pulmanex Adapter 22mm O.D. x 22mm O.D. x 15 mm I.D., manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico
FDA Recall
Terminated
·Unomedical, Inc·Product code BZA·December 2, 2004
Hudson RICA Sheridan, Sher-I-Bronch Accessory Pack, Teleflex Medical, Research Triangle Park, NC 27709. Indicated for use in thoracic surgery, bronchospirometry, for the administration of endobronchial anesthesia and other uses commonly associated with endobronchial tubes.
FDA Recall
Terminated
·Teleflex Medical·Product code BZA·July 31, 2009
Viasys, REF BLD-8101, Pulmanex Carhill Valve Kit: Medium Adult, manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico
FDA Recall
Terminated
·Unomedical, Inc·Product code BZA·December 2, 2004