18 results · 23ms · Sources: EU EUDAMED, US FDA

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STINGRAY LP

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·March 26, 2025

Stingray LP Catheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

STINGRAY? LP

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·May 29, 2026

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526768451·GENUMEDI PSS GREEN I

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100356·COOK EYE SPECULUM #1 SOLID

Elevator

FDA UDI
ELLIQUENCE, LLC·00846338005443·

CMF SYSTEM

FDA UDI
BIOMET MICROFIXATION, INC·00841036076122·

Acetal Liner Impactor 36mm

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215076191·

HEMI IMPLANT; MINI HEMI IMPLANT

FDA 510(k)
FDA Class 2 ·Orthopedic

GYNECARE TVT SECUR SYSTEM

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

BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·June 8, 2018

TRUERESULT

FDA Adverse Event
Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·October 3, 2014

PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

FDA Adverse Event
Malfunction ·MEDTRONIC MILACA, INC.·Product code LWP·June 7, 2013

HEMOPRO2 EXTENSION CABLE

FDA Adverse Event
Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·June 24, 2011

ProScreen 12 Panel Dip Card, Item No. PSD-12BUP

FDA Enforcement
Class III ·Terminated·Ameditech Inc·December 30, 2015

9200C and 9200D Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications.

FDA Enforcement
Class II ·Terminated·Pentax of America Inc·July 26, 2017

ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023

Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024