16 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Medline Silicone Foley Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741426350·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674142635060·
Sonic
FDA UDI
Sonic Innovations, Inc.·05711583024943·CH60 NR, PS GB CHARM 60
BD 10ML SYRINGE LUER-LOK TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 26, 2019
DENALI SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
APOLONIA LASER IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
U BY KOTEX SLEEK
FDA Adverse Event
Malfunction
·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·August 31, 2018
HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
FDA Adverse Event
Death
·THORATEC CORP.·Product code DSQ·May 30, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS·Product code JAA·September 26, 2014
I-STAT THERMAL ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE INC.·Product code JJE·June 21, 2011
U BY KOTEX SLEEK
FDA Adverse Event
Malfunction
·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·June 27, 2018
SYRINGE 10ML LL BNS
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 3, 2019
da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015
da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015
da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015