28 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OSTEONICS ALUMINA C-TAPER HEAD
FDA 510(k)
FDA Class 2
·Orthopedic
TruForm
FDA UDI
Rmo, Inc.·00885797099839·MD 1ST BI BD KT N/L UNIV 97
SCANLAN® Needle Holders
FDA UDI
SCANLAN INTERNATIONAL INC·00846159003178·Puskas™ Jacobson Micro Needle Holder
MULTI-LINK ULTRA
FDA UDI
ABBOTT VASCULAR INC.·08717648035449·MULTI-LINK OTW ULTRA Coronary Stent System 4.50...
MULTI-LINK ULTRA
FDA UDI
ABBOTT VASCULAR INC.·08717648035456·MULTI-LINK OTW ULTRA Coronary Stent System 4.50...
MULTI-LINK ULTRA
FDA UDI
ABBOTT VASCULAR INC.·08717648035432·MULTI-LINK OTW ULTRA Coronary Stent System 4.50...
MULTI-LINK ULTRA
FDA UDI
ABBOTT VASCULAR INC.·08717648035425·MULTI-LINK OTW ULTRA Coronary Stent System 4.50...
VITAL SHIELD GOLD POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
BONUS MECHANICAL WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
INTERSTIM
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·August 9, 2013
T25 STARDRIVE SHAFT F/MATRIX
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code HXX·February 28, 2013
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·August 12, 2014
ASKU
FDA Adverse Event
Death
·MEDTRONIC S.A.·Product code LWS·March 1, 2011
BD ULTRA-FINE¿ INSULIN SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·August 29, 2023
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 29, 2015
TINBN COATED OXF TIB TRAY C LM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code HRY·August 3, 2021
TINBN COATED OXF FEM MED
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code HRY·August 3, 2021
REVERSE SHOULDER SYSTEM STD HUMERAL DIAPHYSIS - CEMENTLESS - 10
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·June 3, 2022
smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024
TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·August 5, 2015