36 results
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22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ExsoMed ITN Cannulated Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
Reduction Forceps
FDA UDI
I.T.S. GmbH·09120047303887·Reduction Forceps, 400mm, 1x1
SURGICASE GUIDE
FDA 510(k)
FDA Class 2
·Neurology
GNR TRAFFIC LIGHT PNA FISH
FDA 510(k)
FDA Class 1
·Microbiology
REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ24.5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·November 11, 2022
THREADED GLENOID BASEPLATE
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·November 5, 2025
VA-LCP-2-COLUMN DRP2.4 VOLAR R SHAFT 3HO
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HRS·June 15, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 21, 2011
LIFEPAK CR PLUS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·September 17, 2008
BD¿ ALCOHOL SWABS
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code LKB·April 2, 2020
M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·October 4, 2024
PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (4X)
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code NKB·October 9, 2019
REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·June 5, 2020
REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø32/+0MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·April 26, 2023
REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 39XØ24.5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSD·July 15, 2022
REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 36XØ24.5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSD·April 26, 2023
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·May 21, 2025
VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identifier No. 10758750005017, REF/Catalog Number/Product Code 855 2630; IVD -- Ortho-Clinical Diagnostics, Pencoed, Bridgend CF35 5PZ, UK --- The VITROS Estradiol test is performed using the VITROS Estradiol Reagent Pack and Calibrators on VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic Systems and VITROS 5600 Integrated Systems.
FDA Enforcement
Class II
·Terminated·ORTHO-CLINICAL DIAGNOSTICS·August 17, 2016
REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 36/+0MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·May 28, 2021
REVERSE SHOULDER SYSTEM 04.01.0208 LAT. GLENOSPHERE 39XØ24.5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSD·May 5, 2022