18 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly
FDA 510(k)
FDA Class 2
·General Hospital
ORTHOCORD HEALIX BR
FDA UDI
Medos International Sàrl·10886705007783·HEALIX BR Anchor w/ORTHOCORD w/Needles TCP/PLGA...
CLINIQA LIQUID-QC HCG CONTROL LEVEL 1, 2, AND 3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GMK NARROW
FDA 510(k)
FDA Class 2
·Orthopedic
GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 4 RIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 9, 2017
GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 4 / 10 MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 16, 2019
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 24, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 3, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·July 12, 2013
GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 2 / 17 MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 26, 2021
HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·April 19, 2024
Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722223, (2) 722224, (3) 722225, (4) 722226
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·February 6, 2024
GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 2 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 15, 2022
GMK-PRIMARY TIBIAL INSERT UC FIXED 3 / 17 MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 27, 2016
GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 4 LEFT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 30, 2016
Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722223, (2) 722224, (3) 722225, (4) 722226
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024
GMK PS TIBIAL INSERT SIZE 3 / 17 MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code JWH·June 11, 2015
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024