14 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X0624350·6mm H x 24mm W x 35mm L x 0 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X06243580·6mm H x 24mm W x 35mm L x 8 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L062435120·6mm H x 24mm W x 35mm L XLIF Trial 12 degree Lo...
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X062435120·6mm H x 24mm W x 35mm L x 12 degrees XLIF
INFINION 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 19, 2018
ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626
FDA 510(k)
FDA Class 1
·Ophthalmic
MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KIT (BAK)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STONEBREAKER SINGLE USE PROBE
FDA Adverse Event
Malfunction
·COOK INC·Product code FFK·March 28, 2018
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 16, 2013
HUDSON BREATHING CIRCUIT, NIV, ADULT
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BZO·March 18, 2011
UNKNOWN PREFILL
FDA Adverse Event
Malfunction
·TYCO HEALTHCARE/KENDALL·Product code NZW·June 17, 2008
TAMPONADE URETERINE BALLOON CATHETER SET
FDA Adverse Event
Injury
·COOK UROLOGICAL·Product code KNA·October 16, 2007
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015