25 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPM-300
FDA 510(k)
FDA Class 2
·Anesthesiology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517636881·CoRoent Ant TLIF PEEK, 13x10x32mm 12°
ArgenZ HT+ 98x14 ML C2B
FDA UDI
ARGEN CORPORATION, THE·D818130322·Dental porcelain/ceramic restoration kit
NUPRO®
FDA UDI
Dentsply Professional·D0031303221·NUPRO® 5% Sodium Fluoride White Varnish, Patien...
N/A
FDA UDI
Tyber Medical, LLC·M695M1303220·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450435434·
Drive
FDA UDI
Drive Devilbiss Healthcare·50822383110115·Stool Seat w/Sq.Gray Cush,2/cs
Portex
FDA UDI
ICU MEDICAL, INC.·15019517075359·
BINAX NOW COVID-19 AG CARD
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·November 10, 2021
EVERCROSS 0.035 OTW PTA DILATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4277
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BINAXNOW COVID-19 AG CARD
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 20, 2021
CONMED ELECTROSURGICAL PENCIL WITH ARGON BEAM COAGULATION
FDA Adverse Event
Malfunction
·CONMED/ASPEN LABS·Product code GEI·September 19, 2000
CONMED ELECTROSURGICAL PENCIL WITH ARGON BEAM COAGULATION
FDA Adverse Event
Malfunction
·CONMED/ASPEN LABS·Product code GEI·September 19, 2000
CATHETER MOUNT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZO·November 25, 2015
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 28, 2025
VENTED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·January 22, 2014
LIKORALL
FDA Adverse Event
Malfunction
·LIKO AB·Product code FSA·March 25, 2013
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·September 30, 2014
AFFINITY 3
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code HDD·May 9, 2011