30 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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APTUS Ulna Shortening 2.5 Product Usage: APTUS Ulna Shortening 2.5 Plates are indicated for fractures and osteotomies, in particular for the ulna.
FDA Enforcement
Class II
·Terminated·Medartis, Inc.·November 5, 2014
Cardiovive 92532 automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Brand name: Burdick. Product name: Cardiovive. Device Operation: Semi-automatic. Color: Blue. Voice Prompt Level: Basic. CPR Metronome: No. Rescue Ready Indicator: Yes. Text Display: Yes. ECG Display: No.
FDA Recall
Terminated
·Cardiac Science Corporation·Product code MKJ·February 3, 2010
Powerheart 9300E automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Brand name: Cardiac Science. Product name: Powerheart. Device Operation: Semi-automatic. Color: Yellow. Voice Prompt Level: Basic. CPR Metronome: No. Rescue Ready Indicator: Yes. Text Display: Yes. ECG Display: No.
FDA Recall
Terminated
·Cardiac Science Corporation·Product code MKJ·February 3, 2010
Powerheart 9300A automated external defibrillator. This fully automatic model does not require the user to press a shock button in order for the device to deliver therapy (when appropriate). Brand name: Cardiac Science. Product name: Powerheart. Device Operation: Fully automatic. Color: Yellow. Voice Prompt Level: Basic. CPR Metronome: No. Rescue Ready Indicator: Yes. Text Display: Yes. ECG Display: No.
FDA Recall
Terminated
·Cardiac Science Corporation·Product code MKJ·February 3, 2010
Powerheart 9390A automated external defibrillator. This fully automatic model does not require the user to press a shock button in order for the device to deliver therapy (when appropriate). Brand name: Cardiac Science. Product name: Powerheart. Device Operation: Fully automatic. Color: Yellow. Voice Prompt Level: Extensive.(Extensive voice prompts provide more detailed instruction on device use, pad placement and CPR performance, as compared to the basic prompts.) CPR Metronome: Yes. Rescue Ready Indicator: Yes. Text Display: Yes. ECG Display: No.
FDA Recall
Terminated
·Cardiac Science Corporation·Product code MKJ·February 3, 2010
Powerheart 9390E automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Brand name: Cardiac Science. Product name: Powerheart. Device Operation: Semi-automatic. Color: Yellow. Voice Prompt Level: Extensive.(Extensive voice prompts provide more detailed instruction on device use, pad placement and CPR performance, as compared to the basic prompts.) CPR Metronome: Yes. Rescue Ready Indicator: Yes. Text Display: Yes. ECG Display: No.
FDA Recall
Terminated
·Cardiac Science Corporation·Product code MKJ·February 3, 2010
INOmax DS (Delivery System) Model 10003 & 10007. The INOMAX DS Delivery System delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators. The INOMAX DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system.
FDA Recall
Terminated
·Ino Therapeutics·Product code MRN·November 30, 2010
Ikaria INOMAX DS Drug Delivery System, model 10003. Ikaria 6 Route 173, Clinton, NJ 08809 USA. The INOMAX DS Delivery System delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators. The INOMAX DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system.
FDA Recall
Terminated
·Ikaria Holdings·Product code MRN·July 21, 2010
AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal devices. Product Usage: AOA Mini RPE Screw Assembly is a component of Herbst, MARA and Fixed Metal devices; removable functional appliances that are to modify the growth of the jaws in a prescribed growth pattern, however, this category is generally attached to the patients upper and lower molars or bicuspids by means of temporary stainless steel crowns or orthodontic bands. Retainer, Screw Expansion, Orthodontic.
FDA Recall
Terminated
·Sybron Dental Specialties·Product code DYJ·June 6, 2013
AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal devices. Product Usage: AOA Mini RPE Screw Assembly is a component of Herbst, MARA and Fixed Metal devices; removable functional appliances that are to modify the growth of the jaws in a prescribed growth pattern, however, this category is generally attached to the patients upper and lower molars or bicuspids by means of temporary stainless steel crowns or orthodontic bands. Retainer, Screw Expansion, Orthodontic.
FDA Enforcement
Class II
·Terminated·Sybron Dental Specialties·September 18, 2013
AOA Distalizer Lock Nut Screw, found in products listed as: Distal Jet, Spring Jet, Mesial Jet, and Uprighter Jet. Removable functional orthodontic appliances that are to modify the growth of the jaws in a prescribed growth pattern.
FDA Recall
Terminated
·Allesee Orthodontic Appliances·Product code DYJ·February 24, 2014
AOA Distalizer Lock Nut Screw, found in products listed as: Distal Jet, Spring Jet, Mesial Jet, and Uprighter Jet. Removable functional orthodontic appliances that are to modify the growth of the jaws in a prescribed growth pattern.
FDA Enforcement
Class II
·Terminated·Allesee Orthodontic Appliances·April 9, 2014
ConMed System 2450 Electrosurgical Generator, REF 60-2450-230, 230V-240V, ConMed Electrosurgery, Centennial, CO. A general-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of high (HF) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site.
FDA Recall
Terminated
·ConMed Electrosurgery·Product code GEI·December 27, 2010
ConMed System 2450 Electrosurgical Generator, REF 60-2450-100, 100 V, ConMed Electrosurgery, Centennial, CO. A general-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of high (HF) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site
FDA Recall
Terminated
·ConMed Electrosurgery·Product code GEI·December 27, 2010
ConMed System 2450 Electrosurgical Generator, REF 60-2450-220, 220 V, ConMed Electrosurgery, Centennial, CO. A general-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of high (HF) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site.
FDA Recall
Terminated
·ConMed Electrosurgery·Product code GEI·December 27, 2010
ConMed System 2450 Electrosurgical Generator, REF 60-2450-120, 120 V, ConMed Electrosurgery, Centennial, CO. A general-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of high (HF) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site.
FDA Recall
Terminated
·ConMed Electrosurgery·Product code GEI·December 27, 2010
ConMed System 2450 Electrosurgical Generator, REF 60-2450-120-69, 120V, (Refurbished), ConMed Electrosurgery, Centennial, CO. A general-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of high (HF) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site.
FDA Recall
Terminated
·ConMed Electrosurgery·Product code GEI·December 27, 2010
The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20ul (list 06J37-018) is an Analyte Specific Reagent (ASR) containing a single vial of CEP 8 spectrum green probe and a Certificate of Analysis (COA). Chromosome enumeration probes (CEP) are chromosome-specific FISH probes that hybridize to highly repetitive human satellite DNA sequences, usually located near centromeres. CEP signals enable the identification and enumeration of human chromosomes in interphase and metaphase cells from fresh and archived samples. The label for CEP 8 SG ASR Probe Kit indicates it is an Analyte Specific Reagent, and analytical and performance characteristics are not established.
FDA Enforcement
Class III
·Terminated·Abbott Molecular·April 30, 2014
GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ, Cardiovascular and Interventional Imaging System.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code OWB·October 21, 2011
USA-002 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and general operational information of the Exer-Rest device, Models AT3800 and AT4700. Brochure: "EXER-REST***A patented, FDA registered, Acceleration Therapeutics device delivering Whole Body Periodic Acceleration to the user for symptomatic relief of a wide range of complaints***Whole Body Periodic Acceleration (WBPA)***WBPA is accomplished utilizing the Ever-Rest device to move the body repetitively head to foot at approximately 140 times a minute. This repetitive motion adds pulses to your natural vascular pulse with each acceleration and deceleration of the body. These additional pulses act on the inner lining of blood vessels (endothelium) throughout the body, a process called pulsatile shear stress, to promote the release of beneficial substances (mediators). These mediators, such as nitric oxide, provide a wide range of health benefits that originate from the user's own body.***Nitric Oxide (NO) is released from endothelial cells that line the arterial walls. NO signals vascular smooth muscle to relax, thereby increasing blood flow throughout the circulation.***NiMS 4400 Biscayne Blvd., Miami, FL 33137 P 305.575.4200 F 305357534201***[email protected] www.nims-inc.com***NIMS, Acceleration Therapeutics and Exer-Rest are registered trademarks of Non-Invasive Monitoring Systems, Inc.***USA-002 Rev A***" Printed marketing brochure
FDA Enforcement
Class II
·Terminated·Non-Invasive Monitoring Systems, Inc.·June 27, 2012