25 results · 32ms · Sources: EU EUDAMED, US FDA

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TWE Nonwovens US, Inc.

FDA registration
TWE Nonwovens US, Inc.·1 product·🇺🇸 United States

PADDED HEAVY DUTY BACK TABLE COVER, 60IN X 90IN / 152 CM X 228 CM

FDA Adverse Event
Injury ·O&M HALYARD, INC.·Product code PUI·July 3, 2023

SUNGO Europe B.V.

Authorized representative
🇳🇱 Netherlands·1571 Manufacturers·20390 Devices

CAPIOX RX15

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·August 6, 2020

CHAPERON GUIDING CATHETER SYSTEM (6F)

FDA Adverse Event
Malfunction ·MICROVENTION, INC.·Product code DQY·June 19, 2019

GREENLIGHT MOXY FIBER OPTIC

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code GEX·June 14, 2023

HALYARD* STANDARD BACK TABLE COVER-NO-44 X 78-44 X 78-SOFT FOLD-HANDI-BIN

FDA Adverse Event
Malfunction ·O&M HALYARD, INC.·Product code PUI·July 15, 2019

HALYARD* STANDARD BACK TABLE COVER-NO-44 X 78-44 X 78-SOFT FOLD-HANDI-BIN

FDA Adverse Event
Malfunction ·O&M HALYARD, INC.·Product code PUI·July 15, 2019

ASPEN

FDA Adverse Event
Injury ·ASPEN LABORATORIES, INC.·Product code GEI·January 21, 1999

CONMED

FDA Adverse Event
Injury ·ASPEN LABORATORIES, INC.·Product code GEI·January 21, 1999

CATARACT PACK

FDA Adverse Event
Malfunction ·ALLEGIANCE HEALTHCARE CORP.·Product code FRL·December 17, 1997

THE NONWOVENS PROJECT, S.L.

Importer
🇪🇸 Spain

IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Iontophoresis transdermal patch.

FDA Enforcement
Class II ·Ongoing·LTS Therapy Systems, LLC·August 6, 2025

IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal patch.

FDA Enforcement
Class II ·Ongoing·LTS Therapy Systems, LLC·August 6, 2025

BATTERY REAMER/DRILL FOR BPL II

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code GEY·December 22, 2025

3M PROCEDURE MASK

FDA Adverse Event
Injury ·3M HEALTH CARE·Product code FXX·February 4, 2014

ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS

FDA Adverse Event
Malfunction ·MEDIVANCE, INC. ¿ 1725056·Product code DWJ·August 21, 2025

ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS

FDA Adverse Event
Malfunction ·MEDIVANCE -1725056·Product code DWJ·April 16, 2025

FLITES (BOXES OF 10), CLIP

FDA Adverse Event
Malfunction ·ARJOHUNTLEIGH POLSKA SP. Z O. O.·Product code FSA·October 23, 2015

IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal patch.

FDA Recall
Open, Classified ·LTS Therapy Systems, LLC·Product code EGJ·May 22, 2025