17 results · 22ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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