14 results · 21ms · Sources: EU EUDAMED, US FDA

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Stand-Alone ALIF Titanium System

FDA 510(k)
FDA Class 2 ·Orthopedic

PASSPORT V MONITOR, MODEL 0998-00-6100

FDA 510(k)
FDA Class 2 ·Cardiovascular

3M LITTMANN SCOPE-TO SCOPE SOFTWARE SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

AP409 -PRIMARY INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER

FDA Adverse Event
Malfunction ·EITAN MEDICAL LTD.·Product code FPA·December 18, 2025

AP205 - INFUSION SET WITH NON-VENTED SPIKE, 1.2UM FILTER AND NEEDLE Y-SITE

FDA Adverse Event
Malfunction ·EITAN MEDICAL LTD.·Product code FPA·June 5, 2024

AP210 - MICROBORE WITH NON-VENTED SPIKE AND 1.2UM FILTER

FDA Adverse Event
Malfunction ·EITAN MEDICAL LTD.·Product code FPA·June 6, 2024

AP210 - MICROBORE WITH NON-VENTED SPIKE AND 1.2UM FILTER

FDA Adverse Event
Malfunction ·EITAN MEDICAL LTD.·Product code FPA·June 17, 2024

CORIN OPTIMIZED POSITIONING SYSTEM

FDA Adverse Event
Injury ·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 2, 2019

AP403 - MICROBORE INFUSION SET WITH VENTED/NON-VENTED SPIKE

FDA Adverse Event
Malfunction ·EITAN MEDICAL LTD.·Product code FPA·March 31, 2026

AP407 - INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER AND NEEDLELESS Y-SITE

FDA Adverse Event
Malfunction ·EITAN MEDICAL LTD.·Product code FPA·March 4, 2026

QUICK FLEX LV LEAD

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, CRMD·Product code OJX·January 13, 2014

MEGA SUTURECUT NEEDLE DRIVERINSTRUMENT

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·June 26, 2013

CS300

FDA Adverse Event
Malfunction ·DATASCOPE CORP·Product code DSP·July 29, 2011

Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024