17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Zenition 90
FDA 510(k)
FDA Class 2
·Radiology
AGXO
FDA UDI
Sbo Hearing A/S·05714464053360·AGXO F100 MINIRITE R C092
Holder, Needle, TC, Castroviejo 18cm
FDA UDI
Geister Medizintechnik GmbH·04057034064986·Holder, Needle, TC, Castroviejo
18cm ...
BD VACUTAINER BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·February 10, 2021
EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG)
FDA 510(k)
FDA Class 2
·Immunology
CADIMPLANT
FDA 510(k)
FDA Class 2
·Radiology
X-FLOW PROSTATECTOMY CATHETER
FDA Adverse Event
Malfunction
·COLOPLAST A/S·Product code EZL·February 6, 2024
X-FLOW PROSTATECTOMY CATHETER
FDA Adverse Event
Malfunction
·COLOPLAST A/S·Product code EZL·February 6, 2024
REFURBISHED COLLEAGUE VOLUMETRIC INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 24, 2008
TENDRIL STS
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·September 9, 2011
FORTE
FDA Adverse Event
Injury
·SMITH&NEPHEW -GERMANY·Product code LPF·July 22, 2013
CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS
FDA Adverse Event
Malfunction
·SYNTHES BETTLACH·Product code HWB·August 17, 2015
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·July 23, 2025
REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø42/+3MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·May 24, 2023
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
BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020