17 results · 23ms · Sources: EU EUDAMED, US FDA

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DRX-EVOLUTION

FDA 510(k)
FDA Class 2 ·Radiology

INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

ACL TIGHTROPE DOUBLE BUNDLE

FDA 510(k)
FDA Class 2 ·Orthopedic

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

ORTHOSIS,PEDICLE SPINAL FIXATION

FDA Adverse Event
Injury ·SYNTHES USA·Product code MNI·December 8, 2015

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

INFUSOR

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·October 4, 2014

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 27, 2011

BD INTIMA-II 24GAX0.75IN PRN SLM NPVC

FDA Adverse Event
Malfunction ·BD SUZHOU (MDS)·Product code FOZ·January 22, 2025

BD INTIMA-II 24GAX0.75IN PRN SLM NPVC

FDA Adverse Event
Malfunction ·BD SUZHOU (MDS)·Product code FOZ·June 7, 2025

ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

FDA Adverse Event
Injury ·SYNTHES USA·Product code NKB·March 25, 2015

Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery.

FDA Enforcement
Class I ·Terminated·Brainlab AG·January 27, 2016