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

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Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software

FDA 510(k)
FDA Class 2 ·Orthopedic

VascuTrak®

FDA UDI
Bard Peripheral Vascular, Inc.·00801741061189·VascuTrak® PTA Dilatation Catheter 2.5 mm x 20 ...

PILLING

FDA UDI
TELEFLEX INCORPORATED·24026704508574·

LEONE SPA

FDA UDI
LEONE SPA·08033707011422·CALIBRA 1ST MOL BANDS W/G8025-02 n.UR 20

Responsive Orthopedics Total Knee Arthroplasty System

FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973101970·Poly Insert MPCS, Size 5L, 20mm

BD NEXIVA CLOSED IV CATHETER SYSTEM

FDA 510(k)
FDA Class 2 ·General Hospital

VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

PELVICOL CELLULAR COLLAGEN MATRIX

FDA Adverse Event
Injury ·TISSUE SCIENCE LABORATORIES·Product code FTL·April 19, 2013

GYRUS ENT G3 WORKSTATION

FDA Adverse Event
Death ·GYRYS ACMI INC.·Product code GEI·September 23, 2014

FREESTYLE LITE

FDA Adverse Event
Malfunction ·Product code NBW·June 28, 2011

BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

FDA Adverse Event
Malfunction ·Product code FOZ·June 25, 2021

UNKNOWN HIP FEMORAL HEAD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·November 8, 2019

UNKNOWN HIP ACETABULAR LINERS

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWY·November 8, 2019

UNKNOWN HIP ACETABULAR CUP

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code HWA·November 8, 2019

UNKNOWN HIP FEMORAL STEM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·November 8, 2019

HANDPIECE MICS

FDA Adverse Event
Malfunction ·MAKO SURGICAL CORP.·Product code OLO·May 23, 2018

Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c) 44, 47, 50, 53 head, Large, Item Number 314-02-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-25; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024