19 results
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30ms
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Sources: EU EUDAMED, US FDA
Medipure Oxygen-LC System
FDA 510(k)
FDA Class 1
·Anesthesiology
LEONE SPA
FDA UDI
LEONE SPA·08033707015109·CALIBRA 1ST MOL BANDS W/G8325-03 n.UL 18
GEN4 INTERACTIVE
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828186780·GEN4 INTERACTIVE
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383507677·Gutta Percha Points is used to root canal filin...
TRINITY ACETABULAR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CLEARLINK PACLITAXEL SETS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·February 2, 2024
ASKU
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 6, 2026
SEE H10
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 17, 2020
ASKU
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 3, 2026
ASKU
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 3, 2026
DUO-VENT CLEARLINK LUER ACTIVATED VALVE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·July 12, 2023
NI
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 23, 2017
FORTIFY ST VR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·October 8, 2014
SPRINT QUATTRO
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·June 8, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 21, 2011
NI
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 23, 2017
VALEO / VALEO II
FDA Adverse Event
Malfunction
·SINTX TECHNOLOGIES (FORMERLY AMEDICA CORP)·Product code MAX·March 25, 2020
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021