16 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Kalitec Direct InSePtion MIS Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
BIO-CLAD ALL POLY CUP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304255920·
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221046543·Unitek(TM) Molar Band General Purpose Wide Hard...
UBM PLUS
FDA 510(k)
FDA Class 2
·Radiology
SHIJIAZHUANG JUNFEI PLASTICS PRODUCTS CO., LTD. POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·April 8, 2016
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·April 8, 2016
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·July 31, 2017
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 29, 2017
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 29, 2017
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 12, 2019
LINOX SD 65/18
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVY·October 10, 2014
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 15, 2011
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL)·Product code DQK·June 11, 2013
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·April 14, 2020
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025