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

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FDA 510(k)
FDA Class 2 ·Cardiovascular

ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800

FDA 510(k)
FDA Class 2 ·Hematology

PROGENY MPSE INTRAORAL DENTAL X-RAY SENSOR

FDA 510(k)
FDA Class 2 ·Dental

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

MAXZERO

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FPA·March 17, 2026

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

INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 4, 2014

OT PING 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 MAXZERO¿ MULTI-FUSE PRESSURE RATED EXTENSION SET

FDA Adverse Event
Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·March 21, 2023

BD MAXZERO¿ EXTENSION SET

FDA Adverse Event
Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·June 10, 2022

MAXZERO NEEDLELESS CONNECTOR

FDA Adverse Event
Malfunction ·CFN MEXICO 215 SA DE CV·Product code FPA·May 12, 2020

BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR

FDA Adverse Event
Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·May 19, 2023

BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR

FDA Adverse Event
Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·May 18, 2023

Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

FDA Enforcement
Class II ·Terminated·Ecolab Inc·September 30, 2015