70 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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AccuChek Spirit insulin infusion pump.
FDA Enforcement
Class II
·Terminated·Roche Diabetes Care, Inc.·June 17, 2015
AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System.
FDA Enforcement
Class II
·Terminated·Roche Diabetes Care, Inc.·June 17, 2015
AccuChek Spirit insulin infusion pump.
FDA Recall
Terminated
·Roche Diabetes Care, Inc.·Product code LZG·April 22, 2015
AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System.
FDA Recall
Terminated
·Roche Diabetes Care, Inc.·Product code LZG·April 22, 2015
Sorin Paradym CRT-D Model 8750 and Sorin Group Paradym sonR CRT-D Model 8770. Made in Italy by Sorin Biomedical CRM S.r.l. Via Crescentino s.n. , 13040 Saluggia (VC) Italy
FDA Recall
Terminated
·ela Medical Llc·Product code NIK·June 7, 2010
Alto MSP (model 617) and Alto 2 MSP (model 627) Implantable cardioverter Defibrillator. Ventricular antitachycardia pacing. Dual chamber arrhythmia detection. biventricular pacing. ELA medical 98, rue Maurice Amoux, 92120 Montrouge- FRANCE. These ICDs are designed to recognize and treat slow or fast Ventricular Tachycardia or Ventricular Fibrillation by continuously monitoring atrial and ventricular activity to identify persistent ventricular arrhythmias and to deliver appropriate therapies.
FDA Recall
Terminated
·ela Medical Llc·Product code MRM·July 19, 2005
Alto VR (model 615) and Alto 2 VR(model 625) Implantable cardioverter Defibrillator. Ventricular antichycardia pacing. Single chamber arrhythmia detection. Antibradycardia pacing. ELA medical 98, rue Maurice Amoux, 92120 Montrouge- FRANCE. These ICDs are designed to recognize and treat slow or fast Ventricular Tachycardia or Ventricular Fibrillation by continuously monitoring ventricular activity to identify persistent ventricular arrhythmias and to deliver appropriate therapies.
FDA Recall
Terminated
·ela Medical Llc·Product code MRM·July 19, 2005
Alto DR (model 614) and Alto 2 DR (model 624) Implantable cardioverter Defibrillator. Ventricular antichycardia pacing. Dual chamber arrhythmia detection. Antibradycardia pacing. ELA medical 98, rue Maurice Amoux, 92120 Montrouge- FRANCE. These ICDs are designed to recognize and treat slow or fast Ventricular Tachycardia or Ventricular Fibrillation by continuously monitoring atrial and ventricular activity to identify persistent ventricular arrhythmias and to deliver appropriate therapies.
FDA Recall
Terminated
·ela Medical Llc·Product code MRM·July 19, 2005
Alto implantable cardioverter defibrillator
FDA Recall
Terminated
·ela Medical Llc·Product code LWS·October 21, 2004
Sentinel Implantable Carioverter-DefibrilIator (ICD) model 2010 is a multi-programmable, two-zone, tiered-therapy device that incorporates anti-tachycardia pacing (ATP), cardioversion, and defibrillation (DEF) tachyarrhythmia therapies. The device also includes a programmable Hot Can electrode and bradycardia pacing support.
FDA Recall
Terminated
·ela Medical Llc·Product code LWS·January 25, 2005
Sorin Group Reply DR Rate responsive dual-chamber pacemaker. Made in Italy by: Sorin BioMedica CRM S.r.l., Via Crescentino s.n., 13040 Saluggia (VC) Italy. ELA Medical, Inc., 14401 West 65th Way, Arvada, CO 80004, USA. REPLY DR is a DDDR-type dual-chamber rate-responsive pacemaker. It is equipped with a physiological sensor and an accelerometer to allow adaptation of pacing to suit the patient's activity. The REPLY device can be programmed to separate pacing and sensing polarities, independent of chamber.
FDA Recall
Terminated
·ela Medical Llc·Product code NVZ·September 23, 2008
Sentinel Implantable Carioverter-DefibrilIator (ICD) model 2012 is a multi-programmable, two-zone, tiered-therapy device that incorporates anti-tachycardia pacing (ATP), cardioversion, and defibrillation (DEF) tachyarrhythmia therapies. The device also includes a programmable Hot Can electrode and bradycardia pacing support.
FDA Recall
Terminated
·ela Medical Llc·Product code LWS·January 25, 2005
ELA Rhapsody SR model 2210. A single chamber rate-responsive pacemaker that uses both minute ventilation and accelerometer sensors. Sterilization with Ethylene Oxide Gas. Sorin Group, ELA medical, 98, rue Maurice Amoux, 92120 Montrouge - France. Made in France.
FDA Recall
Terminated
·ela Medical Llc·Product code DXY·October 25, 2005
Paradym DR Model 8550 and Paradym VR Model 8250, Sterile EO, Manufactured in Italy by Sorin CRM S. r.l., Via Crescentino s.n., 13040 Saluggia(VC) Italy PARADYM DR 8550 and PARADYM VR 8250 are indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, recurrent, poorly tolerated sustained ventricular tachycardia (VT).
FDA Recall
Terminated
·ela Medical Llc·Product code MRM·May 2, 2011
Symphony DR model 2550 and ELA Rhapsody DR model 2510. A dual chamber rate-responsive pacemaker that uses both minute ventilation and accelerometer sensors. Sterilization with Ethylene Oxide Gas. Sorin Group, ELA medical, 98, rue Maurice Amoux, 92120 Montrouge - France. Made in France.
FDA Recall
Terminated
·ela Medical Llc·Product code DXY·October 25, 2005
Forteo [teriparatide (rDNA origin) injection] black starter kits containing Triad alcohol pads. The starter kits look like insulated lunch boxes and contain alcohols pads, needles, instruction guides, and freezer gel packs. Note: the kits do not contain the drug, Forteo. Intended use: Travel starter kits to hold the drug Forteo and supplies needed to deliver the subcutaneous injection.
FDA Recall
Terminated
·Eli Lilly and Company·Product code KMJ·March 17, 2011
LAPAROSCOPY CHOLECYSTECTOMY PACK- (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD UF (2) ABSORBENT TOWELS 15" X 20" UF (1) MAYO STAND COVER REINFORCED UF (4) BANDAGE ADHESIVE W' x 3" L I F (4) DRAPE UTILITY WIT APE UF (1) TUBE SUCTION CONNECT. Y..'' X 12' UF (1) INSUFLAT TUBING SET W/0 RING ADAPTOR UF (1) LAPAROSCOPY ABO. DRAPE W/Pouch UF (1) IMP. GOWN REINFORCED XLge. SMS (2) SYRINGE 60ML W/0 NDL. LILOCK UF (1) SYRNGE 20 cc W/0 NDL ULOCK UF (1) SURGICAL BLADE #15 C/STEEL (1) DRAPE LASER CAMERA W/EL (2) COVER HANDLE LITE LOCK (1) TABLE COVER Reinforced 50" x 90" UF (3) DRAPE SHEET 41 " x 58" SMS (1) SURG. GOWN REINFORCED T/Wrap Lge. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code LRO·May 20, 2014
LAPAROSCOPY CHOLECYSTECTOMY PACK- (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD UF (2) ABSORBENT TOWELS 15" X 20" UF (1) MAYO STAND COVER REINFORCED UF (4) BANDAGE ADHESIVE W' x 3" L I F (4) DRAPE UTILITY WIT APE UF (1) TUBE SUCTION CONNECT. Y..'' X 12' UF (1) INSUFLAT TUBING SET W/0 RING ADAPTOR UF (1) LAPAROSCOPY ABO. DRAPE W/Pouch UF (1) IMP. GOWN REINFORCED XLge. SMS (2) SYRINGE 60ML W/0 NDL. LILOCK UF (1) SYRNGE 20 cc W/0 NDL ULOCK UF (1) SURGICAL BLADE #15 C/STEEL (1) DRAPE LASER CAMERA W/EL (2) COVER HANDLE LITE LOCK (1) TABLE COVER Reinforced 50" x 90" UF (3) DRAPE SHEET 41 " x 58" SMS (1) SURG. GOWN REINFORCED T/Wrap Lge. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
2 pc Full Overlap Vest & Kilt, Single Item, Product Number FVK, Part Numbers REFVK*F, REFVK*M, REFVKB, REFVKD, REFVKE, REFVKF, SEFVK*F, SEFVK*M, SEFVKE, SEFVKXLM Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.
FDA Recall
Terminated
·Burlington Medical, LLC·Product code EAJ·June 7, 2019
ARCHITECT iVancomycin Reagent; an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma on the ARCHITECT i System with STAT protocol capability; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA; list 1P30-25 The ARCHITECT iVancomycin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The ARCHITECT i Vancomycin assay is used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to help ensure appropriate therapy.
FDA Recall
Terminated
·Abbott Laboratories·Product code DLJ·September 13, 2010