26 results · 22ms · Sources: EU EUDAMED, US FDA

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MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS

FDA 510(k)
FDA Class 2 ·Anesthesiology

GRADIA®

FDA UDI
Gc America Inc.·D0470027951·GRADIA® DIRECT X Syringes - 2.7 mL/5 g X-XBW

3D

FDA UDI
Rmo, Inc.·00885797100191·3D QUADACTION MAN 11 ASST OF 4

GRADIA®

FDA UDI
Gc America Inc.·14548161322348·GRADIA® DIRECT X Syringes - 2.7 mL/5 g X-XBW

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776123710·Yasargil Bipolar Forcep

ALLURA XPER FD

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code IZI·May 7, 2025

THE AVITRO LLC, 10 AND 100 USO UNITS/ML HEPARIN SODIUM VAFD

FDA 510(k)
FDA Class 2 ·General Hospital

RIGID GAS PERMEABLE CONTACT LENS

FDA 510(k)
FDA Class 2 ·Ophthalmic

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 18, 2022

DJO SURGICAL

FDA Adverse Event
Injury ·ENCORE MEDICAL, L.P.·Product code JWH·October 17, 2025

THERAKOS CELLEX PHOTOPHERESIS SYSTEM

FDA Adverse Event
Malfunction ·THERAKOS INC.·Product code LNR·December 14, 2015

NI

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code LHI·May 13, 2022

VENTED MICRO VOL.INLET, N/S

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code LHI·March 28, 2022

VALVE SET, EM2400

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code LHI·April 7, 2022

VALVE SET, EM2400

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code LHI·August 8, 2022

FLOGARD

FDA Adverse Event
Malfunction ·SHARP CORPORATION OSAKA JAPAN·Product code FRN·March 13, 2013

ASR 300 SPIKED CUP SIZE 50

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 17, 2011

CELL-DYN SAPPHIRE ANALYZER

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·February 26, 2008

250 ML TPN BAG

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code LHI·May 21, 2021

PUMP 381 PUMP SET (US)

FDA Adverse Event
Injury ·ABIOMED, INC.·Product code OZD·January 28, 2026