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

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GluStitch Twist Tissue Adhesive

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04064984699540·GENUMEDI PSS BLUE SIZE II

ELMED INCORPORATED

FDA UDI
ELMED INCORPORATED·00198506060694·BIOPSY CUP SERRATED, SEMI-RIGID 5 FR DIA (1.6MM...

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776301637·SEMI RIGID BIOPSY DA FCPS 5 FR. 40cm

TMA - Archwire

FDA UDI
ORMCO CORPORATION·00889989029505·TMA REV.CURVE/LOOPS 017X025 32MM PK/5

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450326183·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450316344·

EUROMED SURESKIN III WITH SILVER WOUND DRESSINGS

FDA 510(k)
FDA Unclassified ·Unknown

MECHANICAL WHEELCHAIR

FDA 510(k)
FDA Class 1 ·Physical Medicine

RADIFOCUS OPTITORQUE

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 13, 2022

EON MINI

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 30, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 5, 2011

PUMP MMT- 515PNAP PRDGM INS PL EN US PW

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code LZG·August 27, 2008

5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 60MM

FDA Adverse Event
Injury ·WRIGHTS LANE : SYNTHES USA PRODUCTS LLC·Product code KTT·November 17, 2021

UNK - EXTRACTION INSTRUMENTS: TRAUMA

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code HWB·November 19, 2021

PHASEAL

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code ONB·June 2, 2025

OPTITORQUE ANGIOGRAPHIC CATHETER

FDA Adverse Event
Malfunction ·Product code DQO·January 20, 2021

Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.

FDA Enforcement
Class II ·Terminated·Coloplast Manufacturing US, LLC·December 2, 2020

Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·February 4, 2026

RT-5100 Refractor, a component of the Epic-5100 System.

FDA Enforcement
Class III ·Terminated·Nidek Inc.·December 26, 2018