18 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PHARMACIA DELFIA NEONATAL HTSH KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00681490886277·INSTRUMENT 6905710 CNCLLS ADJ DRILL BIT
VuePoint
FDA UDI
Nuvasive, Inc.·00887517182128·VuePoint Screw, 4.5x10mm Multi Axial
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813020517·GERM TRAY W/SS LD - BEIGE DARBY
SwishPlant® Implant
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307106043·5.7mmD x 10mmL, 6.5mmD Platform
COMP LK SCR 3.5HEX 4.75X35 ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·November 18, 2024
INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
OPTICA 120 ND:YAG SURGICAL LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COMP RVS CNTRL 6.5X35MM ST/RST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·November 18, 2024
COMP LK SCR 3.5HEX 4.75X40 ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·November 18, 2024
COMP LK SCR 3.5HEX 4.75X30 ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·November 18, 2024
COMP LK SCR 3.5HEX 4.75X45 ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·November 18, 2024
COMP RVS CNTRL 6.5X40MM ST/RST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·November 18, 2024
DIMENSION VISTA 1500
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code JGS·January 9, 2013
ORTHO PROVUE
FDA Adverse Event
Malfunction
·MICROTYPING SYSTEMS·Product code KSZ·November 23, 2010
FINELINE II
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code DTB·July 1, 2014
COMPR VRS GLEN PPS MIN TPR ADR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·October 2, 2024
PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017