14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System
FDA 510(k)
FDA Class 2
·Cardiovascular
Dornier MedTech
FDA UDI
DORNIER MEDTECH AMERICA, INC.·00810116022540·600 micron core/1040 micron OD Luer Lock Diode ...
Dornier MedTech
FDA UDI
DORNIER MEDTECH AMERICA, INC.·00810116022526·400 micron core/730 micron OD Luer Lock Diode L...
36M - Black & Veach - Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588011820·36M - Black & Veach - Metal
Sklar®
FDA UDI
SKLAR CORPORATION·10649111151262·SKLIT METZEN SCISS CVD 7"
ELI 200+ AUDICOR
FDA 510(k)
FDA Class 2
·Cardiovascular
MULTIFIX S KNOTLESS FIXATION DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 20, 2025
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·November 17, 2008
CUSTOM PAK
FDA Adverse Event
Injury
·ALCON - HOUSTON·Product code KDD·August 26, 2011
TITANIUM ROOF PILE SCREW 45MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDJ·July 17, 2013
BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM
FDA Adverse Event
Injury
·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FOZ·October 29, 2021
INTIMA-II Y 22GAX1.00IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·June 28, 2021
RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014