86 results · 35ms · Sources: EU EUDAMED, US FDA

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SMARTBUILDER SYSTEM (SB1)

FDA 510(k)
FDA Class 2 ·Dental

revogene™

FDA UDI
GenePoc Inc·00628055344001·The revogene™ instrument is intended for in vit...

LoFric® Primo™

FDA UDI
Wellspect AB·07392532135453·Single Use Urinary Catheter LoFric Primo Nelato...

LoFric® Primo™

FDA UDI
Wellspect AB·07333387043074·Single Use Urinary Catheter LoFric Primo Nelato...

MODIFICATION TO HORIZON SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

EMBO PLUS EMBOLECTOMY CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

SPIROS CLOSED MALE LUER

FDA Adverse Event
Injury ·ICU·Product code FPA·April 11, 2016

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDIC, INC.·Product code KWP·March 15, 2011

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·September 26, 2016

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·July 26, 2016

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·September 11, 2017

APPLIANCE, FIXATION, SPINAL INTERLAMINAL

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·October 25, 2017

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·April 4, 2016

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·April 6, 2017

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code OYC·May 24, 2013

DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·September 30, 2014

CAPSUREFIX NOVUS

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·February 7, 2020

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·October 3, 2011

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 30, 2011