55 results
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39ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DDS Lab China Co, LTD
FDA registration
DDS Lab China Co, LTD·5 products·🇨🇳 China
DDS LAB COSTA RICA SOCIEDAD AMONIMA
FDA registration
DDS LAB COSTA RICA SOCIEDAD AMONIMA·4 products·🇨🇷 Costa Rica
Temporary Titanium Abutments
FDA Enforcement
Class II
·Ongoing·DDS Lab·February 12, 2025
Temporary Titanium Abutments
FDA Recall
Open, Classified
·DDS Lab·Product code NHA·December 6, 2024
SAPIEN M3 DOCK STEERABLE CATHETER
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPU·January 30, 2026
EDSLAB PRESSURE GAUGE
FDA 510(k)
FDA Class 2
·Cardiovascular
EDSLAB CATHETER COVER
FDA 510(k)
FDA Class 2
·Cardiovascular
EDSLAB CLOSED INJECTATE DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
EDSLAB (R) OCCLUSION BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
SWAN-GANZ & EDSLAB HEPARIN COATED CATH.
FDA 510(k)
FDA Class 2
·Cardiovascular
EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH
FDA 510(k)
FDA Class 2
·Cardiovascular
POWERPICC SOLO
FDA Adverse Event
Injury
·C.R. BARD, INC.·Product code LJS·February 24, 2021
TYTIN AMALGAM
FDA Adverse Event
Malfunction
·KERR CORP.·Product code EJJ·December 5, 2000
BREAST IMPLANTS
FDA Adverse Event
Injury
·SILLMED·Product code FTR·October 1, 2016
EVERSENSE SENSOR
FDA Adverse Event
Malfunction
·SENSEONICS INC.·Product code QCD·March 26, 2020
EDSLAB CLOSED INJECTATE DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code KRB·July 8, 2014
EDSLAB CLOSED INJECTATE DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code KRB·July 8, 2014
NATRELLE SILICONE IMPLANT
FDA Adverse Event
Injury
·ALLERGAN·Product code FTR·July 17, 2018
Medline convenience kits: BIB AV FISTULA PACK DYNJ58304B CARDIAC MINOR SURGICOUNT PACK DYNJ56573B ENDOVASCULAR PACK DYNJ29135N EP DEVICE DYNJ65916B FULL LINE ANEURYSM CDS CDS983672P GEN FEM POP #14-RF DYNJ21877W IMPLANT PACK DYNJ39316D OPEN HEART MRNGSD DYNJ58354F PACEMAKER PACK-LF DYNJ0618174N PACEMAKER SETUP PACK DYNJ35761D PACER / CATH LAB PACK-LF DYNJ0972604A PACER CDS CDS983686I PACER PACK DYNJ52059D PK, EP LAB PACEMAKER DYNJ43663A VENOUS ACCESS PACK DYNJ45640B
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·June 24, 2026
SWAN-GANZ & EDSLAB HEPARIN COATED CATHETERS
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DYG·December 17, 2009