25 results
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32ms
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Sources: EU EUDAMED, US FDA
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