12 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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Veta Peritoneal Catheter Kit, Curled, Ref No. M7225 Product Usage: Veta Peritoneal Dialysis Catheters are intended for acute and chronic access to the peritoneal cavity.
FDA Enforcement
Class II
·Terminated·Pfm Medical Inc·December 17, 2014
Viceroy Inflation Syringe, 60mL, without gauge.
FDA Recall
Terminated
·Merit Medical Systems, Inc·Product code MAV·October 21, 2005
Viceroy Inflation Syringe, 60mL, Sterile, Rx only.
FDA Recall
Terminated
·Merit Medical Systems, Inc·Product code MAV·October 21, 2005
Agfa Cronex 10T Radiographic film
FDA Recall
Terminated
·AGFA Corp.·Product code JAC·December 21, 2005
LifeScan OneTouch Ultra Test strips, lot number 2528640
FDA Recall
Terminated
·Lifescan Inc·Product code CGA·November 1, 2005
Fresh Look * Radiance * Moonlight, (phemfilcon) Contact Lenses * -2.75 median, Median Dia:14.5 * Rx only * Ciba Vision, Duluth, GA. The product has been distributed in twin packs containing six pairs of lenses.
FDA Recall
Terminated
·Ciba Vision Corporation·Product code LPL·April 21, 2005
Bard Luminexx 3 Biliary Stent and Delivery System
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code FGE·July 21, 2005
D7120, BG-OX Cartridge, D7120 REF 946-003, and 946-001, cuvettes for the NPT7 series of blood gas analyzers.
FDA Recall
Terminated
·Radiometer America Inc·Product code CHL·January 12, 2005
PROCEED Surgical Mesh is a sterile, thin, flexible laminate mesh designed for the repair of hernias and other fascial deficiencies. The mesh product is comprised of an oxidized regenerated cellulose (ORC) fabric, and PROLENE Soft Mesh, a nonabsorbable polypropylene mesh, which is encapsulated by a polydioxanone polymer. The polypropylene mesh side of the product allows for tissue ingrowth while the ORC side provides a bioresorbable layer that physically separates the polypropylene mesh from underlying tissue and organ surfaces during the wound-healing period to minimize tissue attachment to the mesh. The polydioxanone provides a bond to the ORC layer.
FDA Recall
Terminated
·Ethicon, Inc. US·Product code FTL·January 4, 2006
ARCHITECT STAT Myoglobin Calibrators; list 02K43-01; each kit contains 6 bottles of calibrators ranging from 0 ng/mL to 1200 ng/mL; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories MPG·Product code DDR·October 17, 2005
The PL V Continuum ventilator is a microprocessor controlled, compressorbased, mechanical ventilator. It is intended to control or assist breathing by delivering room air to the patient. PL V Continuum utilizes an internal compressor to generate compressed air for delivery to the patient. Breath delivery is controlled by software algorithms. The user interface on PL V Continuum has a membrane keypad with indicator Light Emitting Diodes (LED) for the selection and acceptance of patient settings and for the display of alarm conditions. PL V Continuum is capable of providing the following types of ventilatory support: . Positive Pressure Ventilation, delivered either invasively (via endotracheal or tracheostomy tube) or non-invasively (via mask or mouthpiece). . Assist/Control, Spontaneous Intermittent Mandatory Ventilation (SIMV) or Continuous Positive Airway Pressure (CP AP) modes of ventilation. . Volume-Controlled (VC). Available in AlC and SIMV. . Pressure-Controlled (PC). Available in AlC and SIMV. . Pressure Support (PS). Available in SIMV and SPONT.
FDA Recall
Terminated
·Respironics California Inc·Product code CBK·November 18, 2005
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018