25 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LnK Posterior Cervical Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
AUVON RECHARGEABLE TENS UNIT MUSCLE STIMULATOR
FDA Adverse Event
Injury
·SHENZHEN AS-TEC TECHNOLOGY CO., LTD·Product code NGX·January 27, 2025
TERATECH MODEL 8IOC4, 8IOL4 & 10LAP4 PROBES
FDA 510(k)
FDA Class 2
·Radiology
ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTION
FDA 510(k)
FDA Class 2
·Clinical Chemistry
UNKNOWN NEXGEN LPS-FLEX KNEE IMPLANT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·March 20, 2015
UNKNOWN NEXGEN LPS-FLEX KNEE IMPLANT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·March 20, 2015
UNKNOWN NEXGEN LPS-FLEX KNEE IMPLANT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code MBH·March 20, 2015
HT ALL STAR WIRE 0.014
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code DQX·April 15, 2013
ISO1000 EXERCISE BICYCLE
FDA Adverse Event
Malfunction
·SCIFIT SYSTEMS, INC.·Product code ION·September 26, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 28, 2011
AUVON TENS UNIT
FDA Adverse Event
Injury
·SHEN ZHEN AS TEC TECHNOLOGY CO LTD·Product code NUH·December 19, 2024
DENALI JUGULAR SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 27, 2023
Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator
FDA Enforcement
Class II
·Ongoing·Abbott·November 8, 2023
DENALI JUGULAR SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·November 21, 2023
DENALI FEMORAL SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 10, 2023
DENALI FEMORAL SYSTEM
FDA Adverse Event
Injury
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 20, 2023
DENALI JUGULAR SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·October 26, 2023
DENALI FEMORAL SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 6, 2023
DENALI FEMORAL SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 20, 2023
DENALI FEMORAL SYSTEM
FDA Adverse Event
Injury
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 11, 2023