52 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NRFit® Caps, Male and Female Neuraxial Tip Caps
FDA 510(k)
FDA Class 2
·General Hospital
HHM
FDA UDI
Oticon A/S·05707131352958·G400 S, MINIRITE 312 2.4G C094 HHM
18M - Burn Relief
FDA UDI
Certified Safety Manufacturing, Inc.·00766588030319·18M - Burn Relief
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515235588·Yasargil Bipolar Fcps w/ plat 1.0mm. 6.3"
Apelo® / Apelo® MIS
FDA UDI
ATLAS SPINE, INC.·M68120103100000·Single Tab Breaker
PUENTE TORNADO MICRO CANNULA SET
FDA UDI
The Wells Johnson Company·B458201031000·Cannula Set, Puente Tornado Micro Cannula Set, ...
URANUS, COMFORTOUCH LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EBI XFIX RAIL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 29, 2025
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008
TRIAGE TOX DRUG SCREEN WITH MTD
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code DJR·July 1, 2011
ARCOS 20X190MM SPLINED TAPER DISTAL
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·July 2, 2013
TMJ UNILATERAL IMPLANTS (BUNDLED COST)
FDA Adverse Event
Injury
·TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS·Product code LZD·September 27, 2022
CUSA EXCEL 36KHZ CURVED EXTENDED MICRO
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES(IRELAND)·Product code LFL·January 28, 2019
Synchro2, 0.014 in x 200cm, SOFT Guidewire with Hydrophilic Coating, UPN Product No. M00326010 REF 2601, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
FDA Enforcement
Class II
·Terminated·Stryker Neurovascular·November 6, 2019
Synchro2, 0.014in x 200cm STANDARD Guidewire with Hydrophilic Coating, UPN Product No. M00326410, REF 2641, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
FDA Enforcement
Class II
·Terminated·Stryker Neurovascular·November 6, 2019
CUSA EXCEL 36KHZ CURVED EXTENDED STANDARDTIP
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES(IRELAND)·Product code LFL·November 19, 2018
Synchro2, 0.014in x 200cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326110, REF 2611, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
FDA Enforcement
Class II
·Terminated·Stryker Neurovascular·November 6, 2019
Synchro2, 0.014in. x 200cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating UPN Product No. M00326420, REF 2642, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
FDA Enforcement
Class II
·Terminated·Stryker Neurovascular·November 6, 2019
PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·August 22, 2019