15 results · 21ms · Sources: EU EUDAMED, US FDA

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Sofia Influenza A+B FIA on Sofia 2

FDA 510(k)
FDA Class 2 ·Microbiology

Sklar®

FDA UDI
SKLAR CORPORATION·10649111122132·LEXER SCISS CRV 8 1/4" TC

SMOOTH STEINMANN PINS, DOUBLE END TROCAR POINT

FDA UDI
Biomet Orthopedics, LLC·00887868016677·

Kyocera Medical Technologies, Inc.

FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523139019·Broach, 38 X 30, 21mm Height 22° Hyperlordotic

Kyocera Medical Technologies, Inc.

FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523139002·Broach, 38 X 30, 19mm Height 22° Hyperlordotic

Kyocera Medical Technologies, Inc.

FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523138999·Broach, 38 X 30, 17mm Height 22° Hyperlordotic

Kyocera Medical Technologies, Inc.

FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523138982·Broach, 38 X 30, 15mm Height 22° Hyperlordotic

BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

PRIMALOK FACET FIXATION SYSTEM

FDA 510(k)
FDA Unclassified ·Unknown

PURITAN BENNETT 980 SERIES VENTILATOR

FDA Adverse Event
Malfunction ·MEDTRONIC/COVIDIEN·Product code CBK·September 17, 2025

RHYTHMIA HDX

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·October 16, 2025

CAPSURE SP NOVUS

FDA Adverse Event
Injury ·MPRI·Product code DTB·October 10, 2014

TERUMO ADVANCED PERFUSION SYSTEM 1

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·June 6, 2013

COAGUCHEK ® XS SYSTEM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·July 14, 2011

TAMPONADE URETERINE BALLOON CATHETER SET

FDA Adverse Event
Injury ·COOK UROLOGICAL·Product code KNA·October 16, 2007