16 results · 22ms · Sources: EU EUDAMED, US FDA

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MOLLI 2 System

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

Gyrus ACMI

FDA UDI
Gyrus ACMI, LLC·00821925032248·MINI-REVERSIBLE VENT TUBE .89 MM I.D. SILICONE

LCP

FDA UDI
Synthes GmbH·10886982164551·4.5MM LCP PROXIMAL TIBIA PLATE 10 HOLES/190MM-R...

N/A

FDA UDI
BIOMET MICROFIXATION, INC·00841036035891·

Prosthesis, Mitral Valve, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Tendyne Transcatheter Mitral Valve System

Trial BiPolar Head

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215045470·

DREAMSTATION AUTO CPAP

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·May 26, 2022

1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME

FDA 510(k)
FDA Class 2 ·Cardiovascular

MEDISIL SILICONE SHEETING

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

Prosthesis, Mitral Valve, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Tendyne™ Transcatheter Mitral Valve System

Prosthesis, Mitral Valve, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Tendyne™ Transcatheter Mitral Valve

Trilogy®

FDA UDI
Zimmer, Inc.·00889024119291·

ALINITY C CALCIUM2

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CJY·March 5, 2026

UPHOLD VAGINAL SUPPORT SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·September 8, 2011

PASS LP

FDA Adverse Event
Injury ·MEDICREA INTERNATIONAL·Product code MNI·November 10, 2014

SQ PATCH

FDA Adverse Event
Injury ·GUIDANT ANGLETON/ST. PAUL·Product code DTB·July 22, 2013