18 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Imaging Plate Scanner, i-Scan
FDA 510(k)
FDA Class 2
·Dental
NuVasive
FDA UDI
Nuvasive, Inc.·00195377105158·NTS Slot Tube, 20x80mm Beveled
MaXcess
FDA UDI
Nuvasive, Inc.·00887517187451·MaXcess Access Blade, 80mm Right
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112656·BARRON CORNEAL PUNCH 8.5MM
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319707616·McCabe Facial Nerve Dissector 5-1/2" (14cm), an...
Aveta Controller
FDA UDI
MEDITRINA, INC.·00850006759019·Aveta Controller
Ti-Fix OLIF Spacer
FDA UDI
Tyber Medical, LLC·M695P32120800·Ti-Fix OLIF Spacer 32 x 12 x 8 (mm) x 0 °
HONOUR™ Spacer System
FDA UDI
NEXXT SPINE, LLC·00889929002858·Cervical PEEK, 6°, 12mm W x 12mm D x 8mm H
HONOUR™ Spacer System
FDA UDI
NEXXT SPINE, LLC·00889929002865·Cervical PEEK, 0°, 12mm W x 12mm D x 8.0mm H
SSD-5000 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
PRESERVE HIP STEM
FDA 510(k)
FDA Class 3
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 6, 2025
I-STAT 6+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·September 28, 2021
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 15, 2011
CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·October 23, 2008
IMMERSION HYDROBATH
FDA Adverse Event
Malfunction
·INVACARE CLEVELAND STREET·Product code ILJ·July 8, 2013
BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025