18 results · 24ms · Sources: EU EUDAMED, 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