10 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME)
FDA 510(k)
FDA Class 2
·Anesthesiology
Integra®
FDA UDI
INTEGRA PAIN MANAGEMENT·10381780260448·CIRCUMCISION TRAY
WU'S 4-WHEELED NEO SCOOTER, WT-M4JR
FDA 510(k)
FDA Class 2
·Physical Medicine
VANTAGE TITAN 3T
FDA 510(k)
FDA Class 2
·Radiology
MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 50
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LPH·June 30, 2017
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 1, 2014
PULSE GEN MODEL 102R
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·May 29, 2013
SUPERDIMENSION INREACH SYSTEM
FDA Adverse Event
Malfunction
·SUPERDIMENSION INC.·Product code JAK·June 17, 2011
Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms Reference Part Number (RPN): ZIMB-22-108 ZIMB-22-118 ZIMB-22-128 ZIMB-22-70 ZIMB-22-84 ZIMB-22-98 ZIMB-24-108 ZIMB-24-118 ZIMB-24-128 ZIMB-24-70 ZIMB-24-84 ZIMB-24-98 ZIMB-26-108 ZIMB-26-118 ZIMB-26-128 ZIMB-26-70 ZIMB-26-84 ZIMB-26-98 ZIMB-28-108 ZIMB-28-118 ZIMB-28-128 ZIMB-28-70 ZIMB-28-84 ZIMB-28-98 ZIMB-30-108 ZIMB-30-118 ZIMB-30-128 ZIMB-30-70 ZIMB-30-84 ZIMB-30-98 ZIMB-32-108 ZIMB-32-108 ZIMB-32-118 ZIMB-32-128 ZIMB-32-70 ZIMB-32-84 ZIMB-32-98 ZIMB-36-108 ZIMB-36-118 ZIMB-36-128 ZIMB-36-84 ZIMB-36-98
FDA Enforcement
Class II
·Terminated·Cook Inc.·September 23, 2020
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024