20 results
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26ms
·
Sources: EU EUDAMED, US FDA
INTEGRITY(TM)
FDA 510(k)
FDA Class 2
·Radiology
PINNACLE®
FDA UDI
B. BRAUN MEDICAL INC.·04046955772803·SCB 3000ML EVA MIXING CONT. SINGLE PACK
1240 1 WAY VALVE
FDA UDI
HANS RUDOLPH, INC.·00874750009190·1240C 1WAY 22MMOD/15MMID PORTS
Trephine
FDA UDI
ELLIQUENCE, LLC·00846338002343·
InFill Lordotic TLIF
FDA UDI
PINNACLE SPINE GROUP, LLC·00814729025080·
Spine Innovation Interbody System
FDA UDI
SPINE INNOVATION, LLC·00817722020335·Expandable Implant 5° x 11mm W x 13mm H x 26mm L
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
REPROCSSED LINVATEC SHAVERS
FDA 510(k)
FDA Class 2
·Orthopedic
GMK-PRIMARY FEMUR STD CEMENTED SIZE 3 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 7, 2023
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·May 27, 2024
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·May 21, 2025
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 14, 2013
FRESENIUS LIBERTY CYCLER
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·September 10, 2014
PINN SECTOR W/GRIPTION 56MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 19, 2011
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·December 21, 2016
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·November 26, 2025
BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 8, 2019
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control¿ Quik-Combo" Connector, REF/Catalog Number 2602M Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).
FDA Enforcement
Class II
·Terminated·ConMed Corporation·April 4, 2018
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 L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025