18 results
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37ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ceramill A-Splint
FDA 510(k)
FDA Unclassified
·Unknown
NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION GLOVES-GREEN,NITRILE POWDER FREE EXAMINATION GLOVES-ORANGE, NITRILE POWDER FREE EXAMINATION GLOVES-BLACK
FDA 510(k)
FDA Class 1
·General Hospital
PERMASHADE VENEER CEMENT
FDA 510(k)
FDA Class 2
·Dental
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 24, 2025
STEM: M-VIZION PROXIMAL BODY 20MM L 80MM STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 17, 2021
STEM: M-VIZION PROXIMAL BODY Ø20MM L 60MM STD WITH HOLES
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 19, 2022
QUICKFLEX XL LV LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·January 13, 2014
CS100
FDA Adverse Event
Malfunction
·DATASCOPE CORP·Product code DSP·July 29, 2011
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 26, 2013
M-VIZION FEMORAL REVISION SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 29, 2025
M-VIZION FEMORAL REVISION SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·March 27, 2025
M-VIZION PROXIMAL BODY HANDLE
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LXH·March 28, 2024
M-VIZION FEMORAL REVISION SYSTEM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LZO·May 28, 2026
STEM: M-VIZION PROXIMAL BODY 20MM L 50MM LAT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·February 24, 2021
M-VIZION INSERTER ROD
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LXH·May 28, 2024
M-VIZION FEMORAL REVISION SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·September 16, 2025
Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL), Pink (pediatrics); MT22430-BLU, Receiver (mg/dL); Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016
GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities and other body parts in patients of all ages.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·August 27, 2014