25 results · 32ms · Sources: EU EUDAMED, US FDA

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Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

J & J INSTRUMENTS

FDA UDI
J & J INSTRUMENTS INC·00817524025545·OPERATING SCI 6.5"" S/S CVD

InCompass®

FDA UDI
ZIMMER SPINE, INC.·00889024400498·

HAMILTON-C2

FDA 510(k)
FDA Class 2 ·Anesthesiology

ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR, MODEL CARDIOCARE 1000I

FDA 510(k)
FDA Class 2 ·Cardiovascular

CONTOUR NEXT

FDA Adverse Event
Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·May 24, 2013

CLICKFINE 32GX4MM DONGBAO 7CT

FDA Adverse Event
Malfunction ·YPSOMED AG·Product code FMI·September 7, 2023

MCGRATH

FDA Adverse Event
Injury ·AIRCRAFT MEDICAL LIMITED·Product code CCW·October 11, 2019

UNKNOWN VLOC PRODUCT

FDA Adverse Event
Injury ·COVIDIEN LP LLC NORTH HAVEN·Product code GAM·January 7, 2022

LEAD MODEL UNKNOWN

FDA Adverse Event
Injury ·CYBERONICS, INC.·Product code LYJ·January 14, 2009

LEAD MODEL UNKNOWN

FDA Adverse Event
Injury ·CYBERONICS, INC.·Product code LYJ·January 13, 2009

2124215-2016-00634

FDA Adverse Event
Injury ·GUIDANT PUERTO RICO BV·Product code NIK·January 17, 2016

8F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

FDA Adverse Event
Injury ·ST. JUDE MEDICAL·Product code MGB·November 4, 2008

PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·August 24, 2011

INTERSTIM

FDA Adverse Event
Injury ·IPG MFG SWITZERLAND·Product code EZW·July 11, 2013

GYNECARE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code OTO·March 16, 2023

ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAT·March 16, 2023

medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9548

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024

Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016

Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016