11 results · 17ms · Sources: EU EUDAMED, US FDA

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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