14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COLLAGEN PERIODONTAL MEMBRANE
FDA 510(k)
FDA Class 2
·Dental
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964022782·The ENDO CARRY-ON Procedure Kit contains all of...
TruForm
FDA UDI
Rmo, Inc.·00885797099853·MN 2ND BI BD KT N/L UNIV 123
Alpha-Tec Systems
FDA UDI
Alpha-TEC Systems, Inc.·00816085024134·Methanol, Absolute
EZ-28 DELIVERY SYSTEM
FDA Adverse Event
Injury
·BAUSCH & LOMB·Product code MSS·December 27, 2012
AEMS V, EMS-1000, MODEL TS-140500 AND AEMS VI, EMS-1000 PLUS, MODEL TS-140600
FDA 510(k)
FDA Class 2
·Physical Medicine
MRI FASTSYSTEM RETRACTOR SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BONE CURETTE-ANGLED
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTF·February 28, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·March 1, 2011
BD PARADIGM LINK GLUCOSE MONITOR
FDA Adverse Event
Malfunction
·NOVA BIOMEDICAL CORP·Product code NBW·February 27, 2008
smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·March 27, 2013
Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.
FDA Enforcement
Class I
·Terminated·Abbott·May 23, 2018
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
FDA Enforcement
Class II
·Ongoing·Covidien·August 28, 2024