11 results · 36ms · Sources: EU EUDAMED, US FDA

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GISH TUBING AND CONNECTORS WITH HA COATING

FDA 510(k)
FDA Class 2 ·Cardiovascular

BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·March 12, 2018

IMPROVED ENLIGHT LV

FDA 510(k)
FDA Class 2 ·Dental

DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

LINEAR? 3-4

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 17, 2026

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 29, 2013

ENDOPATH** ETS45

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 9, 2011

VERSASTEP 5MM SGLUSE DILT/CANN W/EXPSLV

FDA Adverse Event
Malfunction ·PONCE - USS·Product code GCJ·July 21, 2008

WHITE STAR HIGH SPEED VIT CUTTER

FDA Adverse Event
Malfunction ·ABBOTT MEDICAL OPTICS·Product code MLZ·March 24, 2017

WHITE STAR HIGH SPEED VIT CUTTER

FDA Adverse Event
Malfunction ·ABBOTT MEDICAL OPTICS·Product code MLZ·March 24, 2017

CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024