13 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid
FDA 510(k)
FDA Class 1
·General Hospital
HEALIX ADVANCE ORTHOCORD
FDA UDI
Medos International Sàrl·10886705021345·HEALIX ADVANCE BR 3 SUTURE ANCHOR w/ORTHOCORD T...
Sonic
FDA UDI
Sonic Innovations, Inc.·05714464010790·SONIC RADIANT 80 MNR T R BE
AJEX 1200 H / AJEX 240H MOBILE X-RAY GENERATOR
FDA 510(k)
FDA Class 2
·Radiology
I-STETHOS LINK
FDA 510(k)
FDA Class 2
·Cardiovascular
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON·Product code FMI·October 30, 2023
5.5 HEALIX ADVANCE BR3SUT W/OC
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code MAI·November 25, 2019
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 3, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·August 24, 2011
PHILOS 3.5 3HO SST
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code KTW·July 12, 2013
5.5 HEALIX ADVANCE BR 3 SUTURE ANCHOR W/ ORTHOCORD
FDA Adverse Event
Injury
·DEPUY MITEK·Product code MAI·September 24, 2015
5.5 HEALIX ADVANCE BR3SUT W/OC
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code MAI·May 30, 2019
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025