21 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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