55 results · 39ms · Sources: EU EUDAMED, 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