67 results
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13ms
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Sources: EU EUDAMED, US FDA
Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae.
FDA Recall
Terminated
·Keystone Dental Inc·Product code NHA·July 5, 2011
Genesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment Part Number: G71205 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae.
FDA Recall
Terminated
·Keystone Dental Inc·Product code NHA·July 5, 2011
Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Serial # >200318 and < 2039222 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.
FDA Recall
Terminated
·B Braun Medical Inc·Product code KDI·April 1, 2016
Product is packed in a pouch which is labeled as MicroChoice FOOTSWITCH Linvatec LINVATEC CORPORATION LARGO, FL 33773 USA 5020-053
FDA Recall
Terminated
·Linvatec Corp DBA Linvatec/Hal·Product code HWE·January 24, 2003
RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Therapy System offers kinetic therapy for the most aggressive treatment of pulmonary complications.
FDA Recall
Terminated
·Arjo Hospital Equipment AB HANS MICHELSENSGATAN·Product code IKZ·December 3, 2014
Pressure IQ Evolve Mattress; Non-powered mattress replacement system. Intended for patients with medium to high risk for developing pressure ulcers while on a mattress.
FDA Recall
Terminated
·Arjo Hospital Equipment AB HANS MICHELSENSGATAN·Product code IKY·September 1, 2014
Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications.
FDA Recall
Terminated
·Arjo Hospital Equipment AB HANS MICHELSENSGATAN·Product code IKZ·December 3, 2014
TriaDyne Proventa Critical Care Therapy System. The TriaDyne Proventa Critical Care Therapy System provides a comprehensive system of pulmonary and skin care therapies for the critically ill, immobilized patient.
FDA Recall
Terminated
·Arjo Hospital Equipment AB HANS MICHELSENSGATAN·Product code IKZ·December 3, 2014
Pausch Uroview FD fluoroscopic X-ray system UDI number (01)04260491620040 Primarily for urological applications (functional X-ray diagnostics, endourology and minimal invasive urology / surgery). The system, which includes a radiologic / urologic treatment table, maybe used for urological treatment, planning and diagnostic procedures, including but not limited to.
FDA Recall
Terminated
·Hans Pausch Rontgengeratebau Gmbh Graf Zeppelin Strasse 1 Erlangen Germany·Product code JAA·March 14, 2017
KING LT -D Laryngeal Tube, Size 2.5 KLTD2025, King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060. Intended use: Airway management by providing a patent airway to allow patient ventilation.
FDA Recall
Terminated
·King Systems Corp.·Product code CAE·December 15, 2009
CRQ424, Cardiac ResQ Kit, Quantity 3 units, KING SYSTEMS, A Consort Medical Company, Noblesville, IN 46060, www.kingsystems.com, 317-776-6823. Advanced Circulatory Systems, Inc., Eden Prairie, MN, www.advancedcirculatory.com, 877-7377763. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products.
FDA Recall
Terminated
·King Systems Corp.·Product code CAE·January 14, 2011
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone King LAD Patient Size: >70kg Product Usage: Laryngeal airway
FDA Recall
Terminated
·King Systems Corp.·Product code CAE·November 2, 2012
Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK, Product Code 7700RAW2
FDA Recall
Terminated
·Carefusion 2200 Inc
75 N Fairway Dr
Vernon Hills IL 60061-1845·Product code CAE·June 29, 2016
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size 2 / Infant ClearSeal Flexible King LAD Patient Size: 10-20kg Product Usage: Laryngeal airway
FDA Recall
Terminated
·King Systems Corp.·Product code CAE·November 2, 2012
KING LTS-D, SIZE 4, QUANTITY 5 EACH, Distributed by North American Rescue, Greer, South Carolina, 26950-4791, Products with a Mission, Manufactured by King Systems Corporation, 15011 Herriman Boulevard, Noblesville, IN 46060, 317-776-6823, www.kingsystems.com This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products.
FDA Recall
Terminated
·King Systems Corp.·Product code CAE·January 14, 2011
KING SYSTEMS, A Consort Medical Company, KLTD2125, Quantity: 5 PER CASE, KING LT-D, KIT SIZE 2.5, ManufactureR: King Systems Corporation, 15011 Herriman Boulevard, Noblesville, IN 46060, 317-776-6823, Made in the U.S.A. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products.
FDA Recall
Terminated
·King Systems Corp.·Product code CAE·January 14, 2011
KING LT -D Size 3, 10-0002, Oropharyngeal Airway. King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060. Airway management by providing a patent airway to allow patient ventilation.
FDA Recall
Terminated
·King Systems Corp.·Product code CAE·December 15, 2009
King Systems KLTSD414 Quantity, 5 PER CASE KING LTSD KIT SIZE 4 King LT(S)-DTM supraglottic airway Identification Part Number(s): KLTSD414 KING LTSD KIT/KIT/TROUSSE/KIT SIZE 4 Contents: 1 - KLTSD Size 4......(155 - 180cm) .. 1 - 60cc Syringe 1 - Sterile Lubricant 32-5332 05/10 Intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration.
FDA Recall
Terminated
·King Systems Corp.·Product code CAE·December 13, 0013
Masks - Laryngeal Model #'s: AMB321-300-000 AMB321-400-000 AMB321-500-000 LMA12015 LMA12020 LMA12030 LMA12040 LMA12050 LMA12120 LMA12125 LMA12130 LMA12140 and LMA21140 An oropharyngeal airway is a device inserted into a patient's pharynx through the mouth to provide a patent airway.
FDA Recall
Terminated
·Sterilmed Inc·Product code CAE·August 8, 2008
AMS DURA-II Distal Tips, 4 cm, Product Number 72009340, Sterile, American Medical Systems, Inc. Minnetonka, MN
FDA Recall
Terminated
·American Medical Systems·Product code FAE·February 19, 2007