12 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LINK Embrace Shoulder System - Reverse Configuration
FDA 510(k)
FDA Class 2
·Orthopedic
Regatta Lateral System
FDA UDI
Seaspine Orthopedics Corporation·10889981159085·Lateral Implant, 23mm x 14mm x 45mm, 10 Deg
Regatta Lateral System
FDA UDI
Seaspine Orthopedics Corporation·10889981159078·Lateral Implant, 23mm x 14mm x 45mm, 0 Deg
Regatta Lateral System
FDA UDI
Seaspine Orthopedics Corporation·10889981159092·Lateral Implant, 23mm x 14mm x 45mm, 15 Deg
K231485
FDA Adverse Event
Malfunction
·BETA BIONICS, INC.·Product code QFG·October 25, 2025
OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MAINLINE MAXIE HCG URINE PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FG 6301 DUAL CHNL VOL INF PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·November 17, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011
LAMITRODE S8
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 12, 2013
Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and, shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses. Intended for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·March 13, 2019
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022