11 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Footprint Mini PK, 3.5mm Suture Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
IMP,TSV,4.1,11.5,MTX,MG
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·June 15, 2020
PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES
FDA 510(k)
FDA Class 2
·Neurology
CO PILOT/REGIUS UNITEA
FDA 510(k)
FDA Class 2
·Radiology
COBALT HV BN CMT 40G-JAPAN
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LOD·October 29, 2018
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 6, 2014
SYNCHRON® SYSTEMS ALKALINE PHOSPHATASE (ALP) REAGENT
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code CJE·September 3, 2011
STANDARD STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM DE MEXICO S DE RL DE CV·Product code FPO·July 9, 2013
2.0MM BALL NOSE GUIDE WIRE, Item Nos. 281017006 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
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