17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STELLAR 150
FDA 510(k)
FDA Class 2
·Anesthesiology
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169605534·SPACER 2113640 OLIF25 20MM 18 DEG 18X40
COMPREHENSIVE SHOULDER SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304462595·
Comprehensive® Shoulder System
FDA UDI
Biomet Orthopedics, LLC·00887868267871·
7450 RV2 MASK
FDA UDI
HANS RUDOLPH, INC.·00817136021362·7450 V2 MED W/HG & 2700 NRBV
GLOBAL
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295006954·GLOBAL ANCHOR PEG GLENOID PREMIERON X-LINKED PE...
GLOBAL
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295006947·GLOBAL ANCHOR PEG GLENOID SIZE 40mm CEMENTED
MIDMARK IQECG
FDA 510(k)
FDA Class 2
·Cardiovascular
EG-3630UR, ULTRASUND VIDEO GASTROSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·June 7, 2018
COREVALVE TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·December 12, 2017
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 15, 2013
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·September 17, 2014
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·May 24, 2011
EMBLEM S-ICD Model A209
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025