21 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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syngo.plaza
FDA 510(k)
FDA Class 2
·Radiology
Comprehensive® Reverse Shoulder
FDA UDI
Biomet Orthopedics, LLC·00880304555440·
GM HELIX IMPLANT 6.0X10
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·March 2, 2019
RUNTHROUGH NS EXTENSION WIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
GEON RAPID DIGITAL THERMOMETER MODEL: MT-B117, MT-B127, MT-B130, MT-B132FA
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 24, 2024
GM HELIX IMPLANT 6.0X8 MM
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·March 21, 2019
GM HELIX IMPLANT 6.0X10
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·March 20, 2019
GM HELIX ACQUA IMPLANT 6.0X10
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·March 18, 2019
PLEXUR M
FDA Adverse Event
Injury
·OSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC)·Product code MQV·June 20, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 27, 2011
SERVO-S
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·July 21, 2008
GM HELIX IMPLANT 6.0X8
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·June 17, 2019
COMP RVRS SHLDR GLNSP +6 36MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·December 12, 2018
ARCOM XL 44-36 RTNV+3 HMRL BRG
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·December 12, 2018
RUNTHROUGH NS
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 24, 2018
UNKNOWN SCREW
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code PAO·February 4, 2015
COMP NLK SCR 3.5HEX 4.75X35 ST
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWS·May 20, 2022
RUNTHROUGH NS
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 30, 2018
ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327600
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·August 16, 2023