36 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MERON APPLICATION CAPSULES
FDA 510(k)
FDA Class 2
·Dental
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780378648·Integra® Jarit® Cushing Tissue Forceps, 7-3/4",...
N/A
FDA UDI
Tyber Medical, LLC·M695M1304210·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450406427·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450326039·
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
FDA 510(k)
FDA Class 1
·General Hospital
ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
GOBED+
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 24, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 30, 2014
GELITA-SPON/INVOTEC FINAL
FDA Adverse Event
Injury
·GELITA MEDICAL B.V.·Product code KHJ·June 13, 2011
FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth
FDA Enforcement
Class II
·Ongoing·Envisiontec US Llc·February 23, 2022
FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth
FDA Enforcement
Class II
·Ongoing·Envisiontec US Llc·February 23, 2022
MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL·Product code NKM·June 12, 2024
MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL·Product code NKM·March 27, 2024
MITRACLIP
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL·Product code NKM·October 14, 2024
MITRACLIP
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL·Product code NKM·December 20, 2024
MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL·Product code NKM·October 14, 2024
MITRACLIP
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL·Product code NKM·November 8, 2024
MITRACLIP
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL·Product code NKM·August 23, 2024
TRICLIP G4 SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL·Product code NPS·March 7, 2025