16 results · 20ms · Sources: EU EUDAMED, 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