19 results · 39ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

POD SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

EBERLE

FDA UDI
Eberle GmbH & Co. KG·04050052025366·Full Radius Resector 3,5

Ardis®

FDA UDI
ZIMMER SPINE, INC.·00889024334687·

Ardis®

FDA UDI
ZIMMER SPINE, INC.·00889024333956·

VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430

FDA 510(k)
FDA Class 1 ·Ophthalmic

COMBOMAP PRESSURE AND FLOW 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

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

VIDAS HCG

FDA Adverse Event
Malfunction ·BIOMERIEUX SA·Product code JLW·November 26, 2020

SHEATH, 2.9MM OPERATIVE INNER

FDA Adverse Event
Malfunction ·STRYKER ENDOSCOPY-SAN JOSE·Product code HIH·October 3, 2014

OT ULTRAMINI METER

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

INTERSTIM II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·June 22, 2011

NV GXL LNR, LIPPED 32MM ID GROUP 2 CUPS

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JDI·August 26, 2024

VIDAS TSH

FDA Adverse Event
Malfunction ·BIOMERIEUX SA·Product code JLW·November 25, 2020

VIDAS HCG

FDA Adverse Event
Malfunction ·BIOMERIEUX SA·Product code JHI·August 19, 2021