11 results
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17ms
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Sources: EU EUDAMED, US FDA
UC IMU A
FDA 510(k)
FDA Class 2
·Immunology
RIWO-ART
FDA UDI
Richard Wolf GmbH·04055207044735·TROCAR TIP TRIANGULAR SZ 3.8MM WL 219MM distal...
ARTERIOVENOUS FISTULA SETS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PROVOCATIVE SENSITIVITY BALLOON
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PROMUS ELEMENT ¿
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·January 9, 2013
QUATTRODE LEAD KIT
FDA Adverse Event
Injury
·ADVANCED NEUROMODULATION SYSTEMS·Product code LGW·October 28, 2010
OT VERIO TEST STRIPS
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 1, 2014
Escherichia coli Polyvalent 3 Types O86(B7), O114:K90, O125(B15), O127(B8), O128
FDA UDI
REMEL EUROPE LIMITED·05056080501857·
SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades Surgical drill bits, blades, burs, chisels, rasps, taps and reamers are specially designed surgical accessories to help the surgeon cut and drill bone and bony structures. Reprocessed surgical accessories are indicated for use in patients requiring surgery involving bone and bony structures.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·November 18, 2015
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024