17 results · 20ms · Sources: EU EUDAMED, US FDA

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SPICCA Cervical Fusion Cages

FDA 510(k)
FDA Class 2 ·Orthopedic

Mueller MStrips

FDA UDI
Mueller Sports Medicine, Inc.·00074676230672·M-STRIPS 2x4" BOX OF 50

Zavation

FDA UDI
Zavation LLC·00197157002671·CIF 14x18, 6 deg, -07

TALOS®-C HA

FDA UDI
MEDITECH SPINE, LLC·B167522306070·

KAVO EVEREST G-BLANK, KAVO EVEREST G-CERAM, COATING CERAMIC LF-3-PFM, GLAZE AND COLORINGS/STAINING/SHADES

FDA 510(k)
FDA Class 2 ·Dental

LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters

FDA 510(k)
FDA Class 2 ·Orthopedic

UNKNOWN DEPUY 54X28 10D LINER

FDA Adverse Event
Injury ·DEPUY WARSAW·Product code JDI·September 1, 2011

COLLEAGUE CX VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 17, 2008

DURATA STS OPTIM PASSIVE FIXATION, DF-4 CONNECTOR

FDA Adverse Event
Death ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·July 16, 2013

BD MAX¿ ENTERIC VIRAL PANEL

FDA Adverse Event
Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCH·February 23, 2024

BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.

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

CODMAN Disposable Perforator, 14mm. Cranial perforator.

FDA Enforcement
Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025

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 Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020