8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
TWISTCUT ENDOSORB SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 29, 2025
E9000 HIGH SPEED DRILL
FDA Adverse Event
Injury
·CONMED LINVATEC·Product code HRX·May 29, 2013
LASIK
FDA Adverse Event
Injury
·Product code LZS·August 21, 2008
REGENEREX BIOMET PRIMARY TIBIAL TRAY 79MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code MBH·June 17, 2011
Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·February 26, 2014