14 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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U2 Total Knee System E-XPE products
FDA 510(k)
FDA Class 2
·Orthopedic
OsteoMed
FDA UDI
OSTEOMED LLC·00842528109564·4.8mm Cannulated Drill, Large AO Quick Release,...
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776372668·CRILE CLAMP DELICATE STRAIGHT
Cervical Interbody 17mm x 13.5mm x 5mm
FDA UDI
XENCO MEDICAL LLC·B064XM21617051·
17mm X 13.5mm X 5mm CERVICAL INTERBODY
FDA UDI
XENCO MEDICAL LLC·B064XMPH31617051·
CADWELL EASYNET NASAL PRESSURE MODULE
FDA 510(k)
FDA Class 2
·Anesthesiology
MISTRAL-AIR WARMING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
HAMILTON-T1
FDA Adverse Event
Death
·HAMILTON MEDCIAL AG·Product code CBK·September 9, 2024
PROTECTA XT CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·October 10, 2014
SIG MOD TIB TRAY CEM COCR 2
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JWH·June 11, 2013
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 17, 2008
HAMILTON-T1
FDA Adverse Event
Death
·HAMILTON MEDICAL AG·Product code CBK·September 12, 2024
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021