13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFIED BMP TROCHANTERIC PLATES
FDA 510(k)
FDA Class 2
·Orthopedic
artegral life
FDA UDI
Merz Dental GmbH·D7091993510·anteriors; shade D4; mould IS
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198291·AK3 PS Insert Trial Size 5, 10mm
Terason uSmart3200T Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
LUMENVU CATHETER GUIDANCE SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
WALLSTENT RP ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code JCT·March 21, 2025
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·February 19, 2016
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code KWP·April 9, 2015
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·March 7, 2013
PUMP,COLLEAGUE CXE SINGLECHANNEL COLOUR FRENCH LOANER
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·February 16, 2011
REVEAL LINQ
FDA Adverse Event
Malfunction
·IPG MFG SWITZERLAND·Product code DSI·August 8, 2014
WALLSTENT? RP ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·July 21, 2025
Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356 178357 178358 178359 178360 178361 178362 178363 178364 178365 178366 178367 178368 178369 178370 178371 178372 178373 178464 178472 178480 178488 178496 178504 178575 178576 178577 178578 178579 178580 178730 178731 178732 178733 178734 178735 178354S 178754 178755 178756 178757 178758 178759 Product Usage: 1) Correction of revision of unsuccessful osteotomy, arthrodesis or previous joint replacement 2) Tumor resections 3) Revision of previously failed total joint arthroplasty 4) Trauma The ComPreSs Distal Femoral Replacement System is intended for uncemented use.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019