21 results
·
22ms
·
Sources: EU EUDAMED, US FDA
UNITY HUMERAL PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
Mini-Mono®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70605451·Mini-Mono-Brackets Roth 'N' .018" 1000 Brackets...
CT/MR Split-Ring Applicator Set, 32mm, 45ø, Varian
FDA UDI
MICK RADIO NUCLEAR INSTRUMENT, INC·00817330021113·
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482051948·Symmetry® Forceps, Tissue, 1 x 2 Teeth, 18 in
CT/MR Split-Rng IU Tube, 45øx5cm, Varian
FDA UDI
MICK RADIO NUCLEAR INSTRUMENT, INC·00817330021144·
CT/MR Split-Rng IU Tube, 45øx7cm, Varian
FDA UDI
MICK RADIO NUCLEAR INSTRUMENT, INC·00817330021168·
CT/MR Split-Rng IU Tube, 45øx6cm, Varian
FDA UDI
MICK RADIO NUCLEAR INSTRUMENT, INC·00817330021151·
CT/MR Split-Ring IU Tube, 45øx2cm, Varian
FDA UDI
MICK RADIO NUCLEAR INSTRUMENT, INC·00817330021120·
CT/MR Split-Rng IU Tube, 45øx8cm, Varian
FDA UDI
MICK RADIO NUCLEAR INSTRUMENT, INC·00817330021175·
CT/MR Split-Rng IU Tube, 45øx4cm, Varian
FDA UDI
MICK RADIO NUCLEAR INSTRUMENT, INC·00817330021137·
ELIGARD
FDA Adverse Event
Malfunction
·TOLMAR, INC. DISTRIBUTED BY SANOFI AVENTIS·Product code LRP·September 29, 2010
SENTRY EXPANDING INTRODUCER SHEATH (EIS)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TBW
FDA 510(k)
FDA Class 2
·Orthopedic
WAVEWRITER ALPHA PRIME
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 30, 2021
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·March 27, 2013
PINNACLE MTL INS NEUT36IDX50OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·April 6, 2011
NA
FDA Adverse Event
Malfunction
·ASCENT HEALTHCARE SOLUTIONS·Product code HRX·June 12, 2008
UNKNOWN BEARING
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·March 10, 2017
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022