11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200
FDA 510(k)
FDA Class 2
·Cardiovascular
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515028449·Balfour Retractor Side Blades Wire, 2.5", pair
M300 & M400
FDA 510(k)
FDA Class 2
·Physical Medicine
EDLEN IMAGING - GEMINI DUSB
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 14, 2025
MICROPLASTY TIBIAL TRAYS- LOCKING BAR
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·April 18, 2017
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 17, 2014
TOTAL ASR ACET IMP SIZE 54
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·June 21, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 28, 2011
BD PHOENIX¿ NMIC-306
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 20, 2025
MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80 x 12.5 MM; 80 x 15 MM Knee joint replacement prostheses components include femoral, tibial, and patellar components.
FDA Enforcement
Class III
·Terminated·Biomet, Inc.·June 17, 2015