11 results · 24ms · Sources: EU EUDAMED, US FDA

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FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors

FDA 510(k)
FDA Class 2 ·Cardiovascular

Burr

FDA UDI
KATENA PRODUCTS, INC.·00841668113080·BURR FOR ALGERBRUSH 0.5MM

STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115A & 1100C-230A

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

Flexible 19G EBUS Needle

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

EZ-Tip

FDA UDI
Coopersurgical, Inc.·05060488047213·Assisted Reproduction Microtools (Pipettes)

SAMSUNG GALAXY WATCH 5 PRO (Z9NL)

FDA Adverse Event
Malfunction ·SAMSUNG ELECTRONICS AMERICA, INC.·Product code QDA·May 26, 2026

HEARTMATE 3 VAD MODULAR CABLE

FDA Adverse Event
Malfunction ·THORATEC CORPORATION·Product code DSQ·August 30, 2023

TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC·Product code NIQ·November 19, 2008

DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011

LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)

FDA Adverse Event
Injury ·ALLERGAN·Product code LTI·July 19, 2013

Maquet Oasis Dry Suction Water Seal Chest Drain, Single Collection w/AC Reference: 3600-100 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area

FDA Enforcement
Class II ·Terminated·Atrium Medical Corporation·February 22, 2017