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