9 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEMO-WEDGE
FDA 510(k)
FDA Class 1
·Dental
MEGA PLUS MIS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809916490217·MIS Fenestrated Screw M, Ø10.5 x 55mm, Ø6.0mm Rod
PowerX Lipo System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30
FDA 510(k)
FDA Class 2
·Cardiovascular
E-POLY 32MM +3 HIWALL LNR SZ22
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code MAY·May 5, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DTB·October 15, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 23, 2007
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024