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

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Zio AT ECG Monitoring System

FDA 510(k)
FDA Class 2 ·Cardiovascular

MiniSPC Button

FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071150532·16F x 3.5cm MiniSPC Low Profile Suprapubic Cath...

MiniSPC Button

FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071147914·16F x 3.5cm MiniSPC Low Profile Suprapubic Cath...

AFFIRM BREAST BIOPSY GUIDANCE SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

LEKSELL GAMMA KNIFE PERFEXION

FDA 510(k)
FDA Class 2 ·Radiology

TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code JEY·May 31, 2019

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 10, 2014

PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

FDA Adverse Event
MEDEL S.P.A.·Product code BTI·June 11, 2013

HEARTMATE II SYSTEM CONTROLLER

FDA Adverse Event
Malfunction ·THORATEC CORP.·Product code DSQ·June 2, 2011

WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code LZD·August 29, 2017

BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HWC·June 3, 2016

Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

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